A Phase 1 Single- and Multiple-ascending-dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-740792 in Healthy Adult Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
研究概览
简要总结
This is a 3-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose and food effect) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose and drug-drug interaction) will investigate the safety, tolerability, and PK of S-740792, in addition, the effect of multiple doses of S-740792 on the PK of midazolam. Part 3 will investigate the relative bioavailability of S-740792 tablet compared to S-740792 suspension and the food effect on the PK of the S-740792 tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part 3 will be open label.
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
- •Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive).
排除标准
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, 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.
- •Participants who require medication or other treatment (for example, dietary restrictions or physical therapy).
- •Participants who have participated in any other clinical study involving an investigational study intervention or any other type of medical research within 28 days or 5 half-lives of that drug (if known), whichever is longer before signing of the informed consent form for this study or who are currently participating in such a study.
- •Positive test results of the following at screening or within 6 months prior to administration of study intervention:
- •hepatitis B surface antigen
- •hepatitis C virus antibody
- •serological test for syphilis
- •human immunodeficiency virus antigen/antibody
- •drug screen
- •alcohol screen
- •Participants who have used tobacco or nicotine-containing products (including electronic-cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission or a positive cotinine test at screening or on admission.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Part 1 (Single Ascending Dose)
Participants will receive S-740792 or placebo.
干预措施: S-740792 Suspension (Drug)
Part 1 (Single Ascending Dose)
Participants will receive S-740792 or placebo.
干预措施: Placebo (Drug)
Part 2 (Multiple Ascending Dose)
Participants will receive S-740792 or placebo, in addition to midazolam.
干预措施: S-740792 Suspension (Drug)
Part 2 (Multiple Ascending Dose)
Participants will receive S-740792 or placebo, in addition to midazolam.
干预措施: Midazolam (Drug)
Part 2 (Multiple Ascending Dose)
Participants will receive S-740792 or placebo, in addition to midazolam.
干预措施: Placebo (Drug)
Part 3 (Bioavailability)
Participants will receive S-740792 as a suspension and as a tablet.
干预措施: S-740792 Suspension (Drug)
Part 3 (Bioavailability)
Participants will receive S-740792 as a suspension and as a tablet.
干预措施: S-740792 Tablet (Drug)
结局指标
主要结局
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
时间窗: Day 1 through Day 28
Part 3: Plasma Concentration of S-740792
时间窗: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792
时间窗: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
次要结局
- Parts 1 and 2: Plasma Concentration of S-740792(Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28)
- Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792(Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28)
- Part 1: Plasma Concentration of S-740792 After a High-fat Meal(Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14)
- Part 1: Tmax of S-740792 After a High-fat Meal(Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14)
- Part 2: Plasma Concentration of Midazolam After Administration of S-740792(Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration))
- Part 2: Tmax of Midazolam After Administration of S-740792(Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration))
- Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events(Day 1 through Day 62)