跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03816696
NCT03816696已完成1 期

An Open-Label Two-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Dolutegravir in Healthy Subjects

ViiV Healthcare1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年1月23日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label, single-sequence, two-way drug interaction study to investigate the PK, safety and tolerability of GSK3640254 and DTG when administered alone or in combination in healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently involves combination therapy. Data from this study will contribute to dosing recommendations when GSK3640254 and DTG are given in combination. The study will consist of a Screening period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will be approximately 55 days, including Screening.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • •Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • •Body weight >=50 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m^2) (inclusive).
  • •Male or female subjects can participate. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).
  • •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.

排除标准

  • •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • •A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study intervention.
  • •Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
  • •Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Medical Monitor.
  • •Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject.
  • •Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
  • •Presence of Hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to starting study intervention.
  • •Positive Hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention and positive on reflex to Hepatitis C ribonucleic acid (RNA).
  • •Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
  • •ALT >1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
  • •Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
  • •Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
  • •Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory results and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
  • •A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention.
  • •Unable to refrain from the use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and for the duration of the study.
  • •Treatment with any vaccine within 30 days prior to receiving study intervention.
  • •Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.
  • •Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).
  • •Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 56 days.
  • •Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).
  • •Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety for the individual subject.
  • •Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate (males: <45 or >100 beats per minute [bpm] and females: <50 or >100 bpm); PR interval (<120 or >200 milliseconds [msec]); QRS duration (<70 or >110 msec); QTcF interval (males: >450 msec and females: >470 msec).
  • •History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  • •Regular use of tobacco- or nicotine-containing products within 3 months prior to Screening.
  • •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.

研究组 & 干预措施

DTG followed by GSK3640254 followed by DTG+GSK3640254

Experimental

Subjects will receive DTG 50 mg QD on Days 1 through 5 in Period 1 followed by a wash-out period of 4 days. Subjects will then receive GSK3640254 200 mg QD on Days 1 through 7 in Period 2 followed by co-administration of DTG 50 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Period 3.

干预措施: GSK3640254 (Drug)

DTG followed by GSK3640254 followed by DTG+GSK3640254

Experimental

Subjects will receive DTG 50 mg QD on Days 1 through 5 in Period 1 followed by a wash-out period of 4 days. Subjects will then receive GSK3640254 200 mg QD on Days 1 through 7 in Period 2 followed by co-administration of DTG 50 mg QD with GSK3640254 200 mg QD on Days 1 through 7 in Period 3.

干预措施: DTG (Drug)

结局指标

主要结局

Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm

时间窗: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm

时间窗: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.

Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm

时间窗: Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 2: Cmax of GSK3640254 for GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 2: Ctau of GSK3640254 for GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm

时间窗: Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose

Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.

次要结局

  • Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Urinalysis Parameter: pH(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Urinalysis Parameter: pH(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Number of Participants With Urinalysis Dipstick Results(Day 9)
  • Period 2: Number of Participants With Urinalysis Dipstick Results(Day 7)
  • Period 3: Number of Participants With Urinalysis Dipstick Results(Days 4, 7 and 10)
  • Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)(Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours)
  • Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB(Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours)
  • Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB(Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10)
  • Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5)
  • Period 2: Change From Baseline in SBP and DBP(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Change From Baseline in SBP and DBP(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 1: Change From Baseline in Pulse Rate(Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5)
  • Period 2: Change From Baseline in Pulse Rate(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Change From Baseline in Pulse Rate(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 1: Change From Baseline in Respiratory Rate(Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5)
  • Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count(Day 9)
  • Period 2: Change From Baseline in Respiratory Rate(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Change From Baseline in Respiratory Rate(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 1: Change From Baseline in Body Temperature(Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5)
  • Period 2: Change From Baseline in Body Temperature(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Change From Baseline in Body Temperature(Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count(Day 7)
  • Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count(Days 4, 7 and 10)
  • Period 1: Absolute Values for Hematology Parameter: Hemoglobin(Day 9)
  • Period 2: Absolute Values for Hematology Parameter: Hemoglobin(Day 7)
  • Period 3: Absolute Values for Hematology Parameter: Hemoglobin(Days 4, 7 and 10)
  • Period 3: Absolute Values for Hematology Parameter: Hematocrit(Days 4, 7 and 10)
  • Period 1: Absolute Values for Hematology Parameter: Hematocrit(Day 9)
  • Period 2: Absolute Values for Hematology Parameter: Hematocrit(Day 7)
  • Period 1: Absolute Values for Hematology Parameter: Erythrocytes(Day 9)
  • Period 2: Absolute Values for Hematology Parameter: Erythrocytes(Day 7)
  • Period 3: Absolute Values for Hematology Parameter: Erythrocytes(Days 4, 7 and 10)
  • Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Day 9)
  • Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Day 7)
  • Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Days 4, 7 and 10)
  • Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Day 9)
  • Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Day 7)
  • Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Days 4, 7 and 10)
  • Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen(Day 9)
  • Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen(Day 7)
  • Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen(Days 4, 7 and 10)
  • Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase(Day 9)
  • Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase(Day 7)
  • Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase(Days 4, 7 and 10)
  • Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin(Day 9)
  • Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin(Day 7)
  • Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin(Days 4, 7 and 10)
  • Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein(Day 9)
  • Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein(Day 7)
  • Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein(Days 4, 7 and 10)
  • Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase(Day 9)
  • Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase(Day 7)
  • Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase(Days 4, 7 and 10)
  • Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity(Day 9)
  • Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity(Day 7)
  • Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity(Days 4, 7 and 10)
  • Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen(Day 9)
  • Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen(Day 7)
  • Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen(Days 4, 7 and 10)
  • Period 1: Absolute Values for Urinalysis Parameter: pH(Day 9)
  • Period 2: Absolute Values for Urinalysis Parameter: pH(Day 7)
  • Period 3: Absolute Values for Urinalysis Parameter: pH(Days 4, 7 and 10)
  • Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB(Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours)
  • Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB(Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours)
  • Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB(Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10)
  • Period 1: Absolute Values for SBP and DBP(Days 2, 3, 4 and 5)
  • Period 2: Absolute Values for SBP and DBP(Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Absolute Values for SBP and DBP(Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 1: Absolute Values for Pulse Rate(Days 2, 3, 4 and 5)
  • Period 2: Absolute Values for Pulse Rate(Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Absolute Values for Pulse Rate(Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 1: Absolute Values for Respiratory Rate(Days 2, 3, 4 and 5)
  • Period 2: Absolute Values for Respiratory Rate(Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Absolute Values for Respiratory Rate(Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 1: Absolute Values for Body Temperature(Days 2, 3, 4 and 5)
  • Period 2: Absolute Values for Body Temperature(Days 2, 3, 4, 5, 6 and 7)
  • Period 3: Absolute Values for Body Temperature(Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11)
  • Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm(Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm(Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm(Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm(Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 1: Tmax of Dolutegravir for Dolutegravir Arm(Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm(Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 1: T1/2 of Dolutegravir for Dolutegravir Arm(Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm(Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose)
  • Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)(Up to Day 27)
  • Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase(Baseline (Period 1 Day 9) and at Day 7)
  • Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase(Baseline (Period 2 Day 7) and at Days 4, 7 and 10)
  • Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin(Baseline (Day -1) and at Day 9)
  • Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin(Baseline (Period 1 Day 9) and at Day 7)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Unknown
1 期
AV-101 Alone and in Combination With Probenecid in Healthy SubjectsDrug Drug Interaction
NCT05280054VistaGen Therapeutics, Inc.24
已完成
1 期
Drug-drug Interactions Between DWP14012 and Aspirin in Healthy SubjectsDrug Drug Interaction
NCT05304845Daewoong Pharmaceutical Co. LTD.24
已完成
1 期
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With MigraineMigraine
NCT04179474Allergan40
已完成
1 期
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy SubjectsChronic Hepatitis B
NCT03662568Sunshine Lake Pharma Co., Ltd.56
已完成
1 期
Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy SubjectsChronic Hepatitis C
NCT04232514Sunshine Lake Pharma Co., Ltd.28