A Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.
- In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions
- In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal)
- In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)
- In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)
- In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Having given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Part 1a
3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions
干预措施: Tolebrutinib (Drug)
Part 1a
3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions
干预措施: Placebo (Drug)
Part 1b
2 single doses of SAR442168 under fed conditions (moderate-fat breakfast).
干预措施: Tolebrutinib (Drug)
Part 1c
1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast).
干预措施: Tolebrutinib (Drug)
Part 1d
1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast).
干预措施: Tolebrutinib (Drug)
Part 2
3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)
干预措施: Tolebrutinib (Drug)
Part 2
3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)
时间窗: Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21
Part 1b: Total (free and bound) SAR442168 concentrations in CSF
时间窗: From Day 1 to Day 3
Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF
时间窗: From Day 1 to Day 3
Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168
时间窗: From Day 1 to Day approximately 14
Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s)
时间窗: From Day 1 to Day approximately 14
Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168
时间窗: From Day 1 to Day approximately 14
Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s)
时间窗: From Day 1 to Day approximately 14
次要结局
- All Parts: Cmax of SAR442168 metabolite(s)(From Day 1 to Day approximately 14)
- All Parts: Cmax of SAR442168(From Day 1 to Day approximately 14)
- Part 1a, Part 1b and Part 2: tmax of SAR442168(From Day 1 to Day approximately 14)
- Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s)(From Day 1 to Day approximately 14)
- Part 2: AUC0-tau for SAR442168(From Day 1 to Day approximately 14)
- Part 2: AUC0-tau for SAR442168 metabolite(s)(From Day 1 to Day approximately 14)
- Part 1b, Part1c and 1d: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)(From Day 1 to Day approximately 14)
- Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s)(From Day 1 to Day approximately 14)
- Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168(From Day 1 to Day approximately 14)