A Phase 1, 2-part, Open-label, Fixed-sequence Study Evaluating the Effect of Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant
研究概览
简要总结
This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthy males or non-pregnant, non-lactating healthy females
排除标准
- •History of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disorder, as judged by the investigator.
研究组 & 干预措施
Part 1: Camlipixant 50 mg + Rifampin 600 mg
Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
干预措施: Camlipixant (Drug)
Part 1: Camlipixant 50 mg + Rifampin 600 mg
Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.
干预措施: Rifampin (Drug)
Part 2: Camlipixant 50 mg + Rabeprazole 20 mg
Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4
干预措施: Camlipixant (Drug)
Part 2: Camlipixant 50 mg + Rabeprazole 20 mg
Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-Infinity]) of Camlipixant
时间窗: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Part 2: AUC(0-Infinity) of Camlipixant
时间窗: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC[0-t]) of Camlipixant
时间窗: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Part 2: AUC(0-t) of Camlipixant
时间窗: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Part 1: Maximum Observed Concentration (Cmax) of Camlipixant
时间窗: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Part 2: Cmax of Camlipixant
时间窗: Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
次要结局
- Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11)
- Part 2: Tmax of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10)
- Part 1: Terminal Elimination Half-Life (T1/2) Following Administration of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11)
- Part 2: T1/2 Following Administration of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10)
- Part 1: Percentage of AUC0-Infinity Due to Extrapolation From the Time of the Last Observed Concentration to Infinity (% AUC Extrapolation) of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11)
- Part 2: % AUC Extrapolation of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10)
- Part 1: Terminal Elimination Rate Constant of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11)
- Part 2: Terminal Elimination Rate Constant of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10)
- Part 1: Apparent Clearance (CL/F) of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11)
- Part 2: CL/F of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10)
- Part 1: Apparent Oral Volume of Distribution (Vz/F) of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 11)
- Part 2: Vz/F of Camlipixant(Pre-dose, 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose on Day 1 and Day 10)
- Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Treatment-emergent Adverse Events of Medical Interest (TEAEMIs)(Up to Day 22 for Part1 (Day1 post-dose until Day4 pre-dose of rifampin [Camlipixant 50mg];From Day4 dosing until Day11 pre-dose of camlipixant [Rifampin 600mg];From camlipixant dosing on Day11 until end of study [Day 22] [Camlipixant 50mg+Rifampin 600mg])
- Part 2: Number of Participants With TEAEs, TESAEs and TEAEMIs(Upto Day21 for Part2(Day1 postdose until Day4 predose of rabeprazole [Camlipixant 50mg];From Day4 dosing until Day10 predose of camlipixant [Rabeprazole 20mg];From camlipixant dosing on Day10 until end of study[Day21] [Camlipixant 50mg+Rabeprazole 20mg])
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings(Day 4, Day 11, and Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in 12-Lead ECG Findings(Day 4, Day 10, and Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP), and Heart Rate(Day 11 and Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: DBP, SBP, and Heart Rate(Day 10 and Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature(Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Vital Signs: Respiratory Rate and Oral Temperature(Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination(Up to Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Physical Examination(Up to Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters(Up to Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Hematology Parameters(Up to Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters(Up to Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Clinical Chemistry Parameters(Up to Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters(Up to Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Coagulation Parameters(Up to Day 12)
- Part 1: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis(Up to Day 13)
- Part 2: Number of Participants With Abnormal Clinically Significant Changes in Urinalysis(Up to Day 12)