A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of M5049 Administered Orally in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
研究概览
简要总结
The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight between 50 to 100 kilogram (kg)
- •Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)
- •Other protocol defined inclusion criteria could apply
排除标准
- •History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
- •History of splenectomy
- •History of epilepsy, other neurological disorders, or neuropsychiatric conditions
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Part A: M5049
干预措施: M5049 (Drug)
Part A: Placebo
干预措施: Placebo (Drug)
Part B: M5049
干预措施: M5049 (Drug)
Part B: Placebo
干预措施: Placebo (Drug)
Part C: M5049
干预措施: M5049 (Drug)
结局指标
主要结局
Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
时间窗: Day 1 up to Day 21
Part A: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings
时间窗: Day 1 up to Day 21
Number of participants with clinically significant changes will be reported.
Part C: Apparent Terminal Half-life (t1/2) of M5049
时间窗: Pre-dose up to Day 6
Part C: Apparent Volume of Distribution (Vz/f) of M5049
时间窗: Pre-dose up to Day 6
Part C: Maximum Observed Plasma Concentration (Cmax) of M5049
时间窗: Pre-dose up to Day 6
Part C: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)
时间窗: Pre-dose up to Day 6
Part B: Occurrence and Severity of TEAEs and SAEs
时间窗: Day 1 up to Day 33
Part B: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings
时间窗: Day 1 up to Day 33
Number of participants with clinically significant changes will be reported.
Part C: Time to Reach Maximum Plasma Concentration (tmax) of M5049
时间窗: Pre-dose up to Day 6
Part C: Elimination Rate Constant (λz) of M5049
时间窗: Pre-dose up to Day 6
Part C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049
时间窗: Pre-dose up to Day 6
Part C: Total Body Clearance (CL/f) of M5049
时间窗: Pre-dose up to Day 6
次要结局
- Part B: Dose Normalized Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau/D) of M5049(Pre-dose up to Day 19)
- Part C: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)(Day 1 up to Day 23)
- Part A: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)(Pre-dose up to Day 6)
- Part A: Time to Reach Maximum Plasma Concentration (tmax) of M5049(Pre-dose up to Day 6)
- Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049(Pre-dose up to Day 6)
- Part A: Apparent Volume of Distribution (Vz/f) of M5049(Pre-dose up to Day 6)
- Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax/D) of M5049(Pre-dose up to Day 6)
- Part B: Maximum Observed Blood Concentration (Cmax) of M5049(Pre-dose up to Day 19)
- Part B: Time to Reach Maximum Plasma Concentration (tmax) of M5049(Pre-dose up to Day 19)
- Part A: Elimination Rate Constant (λz) of M5049(Pre-dose up to Day 6)
- Part A: Total Body Clearance (CL/f) of M5049(Pre-dose up to Day 6)
- Part B: Apparent Terminal Half-life (t1/2) of M5049(Pre-dose up to Day 19)
- Part B: Apparent Volume of Distribution (Vz/f) of M5049(Pre-dose up to Day 19)
- Part B: Accumulation Ratio for AUCtau(Racc AUCtau) of M5049(Pre-dose up to Day 19)
- Part B: Plasma Concentration Prior to the Next Dose (C trough) of M5049(Pre-dose up to Day 19)
- Part A: Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) on Digital Holter Electrocardiograms (ECG) at Day 2(Baseline, Day 2)
- Part C: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings(Day 1 up to Day 23)
- Part A: Apparent Terminal Half-life (t1/2) of M5049(Pre-dose up to Day 6)
- Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049(Pre-dose up to Day 19)
- Part B: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)(Pre-dose up to Day 19)
- Part A: Maximum Observed Blood Concentration (Cmax) of M5049(Pre-dose up to Day 6)
- Part A: Time Matched Plasma Concentration of M5049(Pre-dose up to Day 6)
- Part B: Elimination Rate Constant (λz) of M5049(Pre-dose up to Day 19)
- Part B: Peak trough Ratio of M5049(Pre-dose up to Day 19)
- Part B: Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) on Digital Holter Electrocardiograms (ECG) at Day 2(Baseline, Day 2)
- Part A: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/D) of M5049(Pre-dose up to Day 6)
- Part B: Total Body Clearance (CL/f) of M5049(Pre-dose up to Day 19)
- Part B: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau)(Pre-dose up to Day 19)
- Part B: Accumulation Ratio for Cmax (Racc Cmax) of M5049(Pre-dose up to Day 19)
- Part B: Dose Normalized Maximum Observed Plasma Concentration at Steady State (Cmaxss/D) of M5049(Pre-dose up to Day 19)
- Part B: Time Matched Plasma Concentration of M5049(Pre-dose up to Day 19)