A Two-Part, Randomized, Open-Label, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Fixed-Dose Combinations of GSK3640254 and Dolutegravir and to Assess the Effect of Food on the Select Fixed Dose Combination of GSK3640254 and Dolutegravir in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Part 1: Cmax of DTG
研究概览
简要总结
This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
- •Participants capable of giving signed informed consent.
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 gastro intestinal anatomy or motility (for example [e.g.], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
- •Prior cholecystectomy surgery (prior appendectomy is acceptable).
- •Clinically significant illness, including viral syndromes within 3 weeks of dosing.
- •Participant with known or suspected active Coronavirus disease (COVID)-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment.
- •Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
- •Prior exposure to GSK3640254 or prior intolerance to DTG in this or another clinical study.
- •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 in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular 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 participant.
研究组 & 干预措施
Part 1 : Treatment sequence ABC
Participants will receive a single oral dose of GSK3640254 25 milligrams (mg) (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 1, followed by a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 2. In Period 3, participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C).
干预措施: GSK3640254 (Drug)
Part 1 : Treatment sequence ABC
Participants will receive a single oral dose of GSK3640254 25 milligrams (mg) (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 1, followed by a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 2. In Period 3, participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C).
干预措施: DTG (Drug)
Part 1 : Treatment sequence ABC
Participants will receive a single oral dose of GSK3640254 25 milligrams (mg) (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 1, followed by a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 2. In Period 3, participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C).
干预措施: GSK3640254/DTG (Drug)
Part 1 : Treatment sequence BCA
Participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 1, followed by a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A).
干预措施: GSK3640254 (Drug)
Part 1 : Treatment sequence BCA
Participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 1, followed by a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A).
干预措施: DTG (Drug)
Part 1 : Treatment sequence BCA
Participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B) in Period 1, followed by a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A).
干预措施: GSK3640254/DTG (Drug)
Part 1 : Treatment sequence CAB
Participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in period 1, followed by a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B).
干预措施: GSK3640254 (Drug)
Part 1 : Treatment sequence CAB
Participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in period 1, followed by a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B).
干预措施: DTG (Drug)
Part 1 : Treatment sequence CAB
Participants will receive a single oral dose of GSK3640254 / DTG, 150 mg/50 mg (1 x bilayer tablet) FDC administered under moderate fat and calorie conditions (Treatment C) in period 1, followed by a single oral dose of GSK3640254 25 mg (2 x tablets), GSK3640254 100 mg (1 x tablet) and DTG 50 mg (1 x tablet) administered together under moderate fat and calorie conditions (reference) (Treatment A) in Period 2. In Period 3 participants will receive a single oral dose of GSK3640254/DTG, 150 mg/50 mg (1 x monolayer tablet) FDC administered under moderate fat and calorie conditions (Treatment B).
干预措施: GSK3640254/DTG (Drug)
Part 2 : Treatment sequence DE
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 2.
干预措施: GSK3640254/DTG (Drug)
Part 2 : Treatment sequence ED
Participants will receive a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under fasted conditions (Treatment E) in Period 1 followed by a single oral dose of selected FDC from Part 1 of GSK3640254/DTG, 150 mg/50 mg administered under high fat and calorie conditions (Treatment D) in Period 2.
干预措施: GSK3640254/DTG (Drug)
结局指标
主要结局
Part 1: Cmax of DTG
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Part 1: AUC(0-inf) of DTG
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK3640254
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254.
Part 1: AUC(0-t) of DTG
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Part 2: AUC(0-inf) of GSK3640254
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Time t (AUC[0-t]) of GSK3640254
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Part 1: Maximum Observed Concentration (Cmax) of GSK3640254
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Part 2: AUC(0-t) of GSK3640254
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period.
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Part 2: Cmax of GSK3640254
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of GSK3640254.
Part 2: AUC(0-inf) of DTG
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Part 2: Cmax of DTG
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
Part 2: AUC(0-t) of DTG
时间窗: Pre-dose, 30 minutes, 1 hour, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96 hours post dose in each treatment period
Blood samples were collected at indicated time points for PK analysis of DTG.
次要结局
- Part 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Number of Participants With Non-Serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)(Up to 17 days)
- Part 1: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values for Hematology Parameter: Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values for Hematology Parameter: Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values for Hematology Parameters: Hematocrit(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2 : Absolute Values for Urinalysis Parameter: Specific Gravity(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Number of Participants With Non-SAEs and SAEs(Up to 9 days)
- Part 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values for Hematology Parameter: Erythrocytes(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values for Hematology Parameter: Erythrocytes(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values for Hematology Parameters: Hematocrit(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Absolute Values of Clinical Chemistry Parameters: Calcium, Carbon-dioxide (CO2), Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap(Baseline (Day -1), and Days 2, 5, and 7)
- Part 2: Absolute Values for Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Creatinine Kinase (CK)(Baseline (Day -1), and Days 2, 5, and 7)
- Part 2: Absolute Values of Clinical Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Absolute Values of Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein(Baseline (Day -1), and Days 2, 5, and 7)
- Part 1: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein(Baseline (Day -1) and Days 2, 5, 7)
- Part 2: Change From Baseline in Clinical Chemistry Parameters: Albumin, Globulin and Protein(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values for Chemistry Parameters: Serum Lipase, Serum Amylase(Baseline (Day -1), and Days 2, 5, and 7)
- Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Absolute Values of Clinical Chemistry Parameters: Albumin, Globulin and Protein(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Bilirubin, and Urate(Baseline (Day -1), and Days 2, 5, and 7)
- Part 1: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Change From Baseline in Clinical Chemistry Parameters: Calcium, CO2, Chloride, Glucose, Potassium, Sodium, Urea Nitrogen, Phosphorus, Triglycerides, Cholesterol, and Anion Gap(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Number of Participants With Urinalysis Dipstick Results: Glucose(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, LDH, CK(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in Clinical Chemistry Parameters: Lipase and Amylase(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Number of Participants With Urinalysis Dipstick Results: Glucose(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Absolute Values for Urinalysis Parameters: Potential of Hydrogen (pH)(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Number of Participants With Urinalysis Dipstick Results: Protein(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Number of Participants With Urinalysis Dipstick Results: Ketones(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Number of Participants With Urinalysis Dipstick Results: Protein(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Number of Participants With Urinalysis Dipstick Results: Occult Blood(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity(Baseline (Day -1) and Days 2, 5, and 7)
- Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen(Baseline (Day -1) and Days 2, 5 and 7)
- Part 1: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to Day 17)
- Part 1: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to Day 17)
- Part 1: Absolute Values of Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7)
- Part 1: Number of Participants With Urinalysis Dipstick Results: Occult Blood(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Change From Baseline for Urinalysis Parameter: Potential of Hydrogen(Baseline (Day -1) and Days 2, 5, and 7)
- Part 1: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to Day 17)
- Part 2: Absolute Values of Vital Signs: Pulse Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7)
- Part 2: Absolute Values of Vital Signs: Respiratory Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7)
- Part 1: Change From Baseline in Vital Signs: Oral Temperature(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7)
- Part 2: Number of Participants With Urinalysis Dipstick Results: Ketones(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Number of Participants With Urinalysis Dipstick Results: Bilirubin and Nitrite(Baseline (Day -1) and Days 2, 5 and 7)
- Part 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval(Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, Days 5 and 7)
- Part 2: Number of Participants With Worst Case Urine Parameter: Glucose Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to Day 9)
- Part 2: Number of Participants With Worst Case Urine Parameter: Protein Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to Day 9)
- Part 1: Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)(Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Day 5)
- Part 2: Absolute Values of Vital Signs: Oral Temperature(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Day 5 and 7)
- Part 2: Number of Participants With Worst Case Urine Parameter: Erythrocytes Results by Maximum Grade Increase Post-Baseline Relative to Baseline(Up to Day 9)
- Part 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF(Baseline (Day 1, pre-dose), and Day 1: 2, 4, 6 hours, and Days 5, 7)
- Part 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval(Baseline (Day 1, Pre-dose), and Day 1: 2, 4, 6 hours, and Day 5)
- Part 2: Absolute Values of Vital Signs: DBP and SBP(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5 and 7)
- Part 1: Absolute Values of Vital Signs: Pulse Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7)
- Part 1: Absolute Values of Vital Signs: Respiratory Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5 and 7)
- Part 1: Change From Baseline in Vital Signs: Pulse Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7)
- Part 1: Change From Baseline in Vital Signs: Respiratory Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7)
- Part 1: Change From Baseline in Vital Signs: DBP and SBP(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, and 7)
- Part 2: Change From Baseline in Vital Signs: DBP and SBP(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7)
- Part 2: Change From Baseline in Vital Signs: Pulse Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7)
- Part 2: Change From Baseline in Vital Signs: Respiratory Rate(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, and 7)
- Part 1: Absolute Values of Vital Signs: Oral Temperature(Baseline (Day 1, pre-dose), and Day 1: 24, 48, 72 hours, Days 5, 6 and 7)
- Part 2: Change From Baseline in Vital Signs: Oral Temperature(Baseline (Day 1, pre-dose), and Day 1: 24, 48 hours, Days 5, 6 and 7)