NCT06497517已完成1 期
A Phase 1, Single Center, Single Dose, Open-Label, Randomized, 2-Way Crossover Study to Investigate the Food Effect on the Pharmacokinetics of Camlipixant in Healthy Male and Female Participants
Bellus Health Inc. - a GSK company1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年7月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf)
研究概览
简要总结
This study is a single center, single dose, open-label, randomly assigned 2-way crossover study. The study will investigate the food effect on the pharmacokinetics of Camlipixant (GSK5464714) in healthy male and female participants. Eligible participants will be randomized to pre-defined sequences. There will be a washout of minimum 7 days between each dose of treatment period.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECGs including the following:
- •Seated blood pressure (after 5 mins), average of 3 readings, is greater than or equal to (>=) 90/55 millimetre of mercury (mmHg) and less than or equal (<=)140/90 mmHg at the screening visit.
- •Seated heart rate, average of 3 readings, is >= 40 beats per minutes (bpm) and <= 99 bpm at the screening visit.
- •Corrected QT interval using the Fridericia formula (QTcF) on ECG, average of 3 readings, is <= 450 millisecond (msec) and 12-lead ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit.
- •Aspartate transferase (AST), Alanine transaminase (ALT), direct bilirubin, indirect bilirubin, and total bilirubin within normal ranges at the screening visit and check-in. Only abnormal values up to 1.5 x upper limit of normal may be repeated once
- •Continuous non-smoker who has never used nicotine- or tobacco-containing products or light smoker for the last 6 months prior to study screening
- •Body weight ≥ 50.0 kilogram (kg) and Body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m2) (inclusive) at Screening.
- •Male and female participants must follow protocol-specified contraception guidance.
- •Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies
- •Is a woman of nonchildbearing potential (WONCBP)
- •Is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective
- •A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study intervention (i.e., Day -1 of each treatment period)
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Must be willing and able to comply with the protocol.
排除标准
- •History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- •Have a history of malignant neoplasm (excepting definitively treated non melanoma skin cancer or carcinoma in situ of the uterine cervix, which may be enrolled at any time) within the last 5 years.
- •Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing.
- •Participation in the clinical study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 3 months.
- •Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- •Current enrolment or past participation in another investigational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days or 5.5 half-lives before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- •Current enrolment or past participation in this clinical study.
- •Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
- •Positive Human immunodeficiency virus (HIV) antibody test.
- •Positive coronavirus (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) polymerase chain reaction test at check-in.
- •Presence of Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
- •Positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to starting study intervention.
- •Total bilirubin >1.5x upper limit of normal (ULN), including participants with Gilbert's syndrome.
- •Regular alcohol consumption within 6 months prior to the clinical study defined as: For sites in United States of America (USA), an average weekly intake of 3 units for males or 1.5 units for females.
- •History of known drugs of abuse, including tetrahydrocannabinol, in last 5 years.
- •Sensitivity to heparin or heparin-induced thrombocytopenia.
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the clinical study.
- •Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.), within past 30 days prior to signing the consent and during the study.
- •Any dietary restrictions that would prevent the participant from consuming the site menu/meals.
研究组 & 干预措施
Sequence 1
Experimental
In sequence 1, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 under fasting condition (Treatment A), followed by single dose of GSK5464714 in fed condition (Treatment B). There will be a washout period of minimum 7 days between each period.
干预措施: GSK5464714- Camlipixant (Drug)
Sequence 2
Experimental
In sequence 2, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 in fed condition (Treatment B), followed by single dose of GSK5464714 under fasting condition (Treatment A). There will be a washout period of minimum 7 days between each period.
干预措施: GSK5464714- Camlipixant (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf)
时间窗: Up to Day 3 for each period
Maximum Observed Plasma Drug Concentration (Cmax)
时间窗: Up to Day 3 for each period
次要结局
- Apparent Oral Clearance (CL/F)(Up to Day 3 for each period)
- Time to Maximum Observed Plasma Drug Concentration (Tmax)(Up to Day 3 for each period)
- Apparent Terminal Phase Half-Life (t½)(Up to Day 3 for each period)
- Absolute Values for Clinical Laboratory Parameters Over Time(Up to 3 weeks)
- Absolute Values for 12- Lead Electrocardiogram (ECG) Over Time(Up to 3 weeks)
- Absolute Values for Vital Sign Measurements Over Time(Up to 3 weeks)
- Changes from Baseline for Clinical Laboratory Parameters Over Time(Up to 3 weeks)
- AUC from Time Zero to Last Quantifiable Concentration [AUC(0-t)(Up to Day 3 for each period)
- Apparent Volume of Distribution (Vz/F)(Up to Day 3 for each period)
- Number of Participants Reported for Adverse events, Serious Adverse Events and Adverse Events of Special Interest(Up to 3 weeks)
- Changes from Baseline for 12- Lead ECG Over Time(Up to 3 weeks)
- Changes from Baseline for Vital Sign Measurements Over Time(Up to 3 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 TabletsHealthyNCT02373046Lexicon Pharmaceuticals30
Unknown
1 期
Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy SubjectsHealthyNCT03791463Peking University First Hospital14
已完成
1 期
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270Healthy ParticipantsNCT06536036Jiangsu Simcere Pharmaceutical Co., Ltd.16
已完成
1 期
A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two ComponentsDiabetes Mellitus, Type 2NCT01780051Dalim BioTech Co., Ltd.48
已完成
1 期
Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy SubjectsHealthyNCT02609139Pfizer18