Single-center, Double-blind, Randomized, Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects, Including Food Effect, Mass Balance, and Metabolite Profiling
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)
研究概览
简要总结
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- •Healthy male (Part A and B) and female subjects (Part B) aged between 18 and 55 years (inclusive) at Screening.
- •Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
- •Male subjects with a partner who might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use a highly effective method of contraception.
- •Inclusion Criteria for Part B:
- •Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -
- •They must consistently and correctly use a highly effective method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner.
- •Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -
排除标准
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
- •Exclusion Criteria for the ADME evaluation (Part A) only:
- •Radiation exposure, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionising Radiation Regulations, must not participate in the study.
- •Participation in any study involving administration of any 14C radiolabeled compound within the 12 months prior to Screening.
- •Exclusion Criteria for Part B:
- •Pregnant or lactating women.
研究组 & 干预措施
Part A (SAD): Dose A5
Single dose A5 of ACT-1014-6470; soft capsule for oral use.
干预措施: ACT-1014-6470 (SAD) (Drug)
Part A (SAD): Dose A1
Single dose A1 of ACT-1014-6470; soft capsule for oral use.
干预措施: ACT-1014-6470 (SAD) (Drug)
Part A (SAD): Dose A1
Single dose A1 of ACT-1014-6470; soft capsule for oral use.
干预措施: Placebo (SAD) (Drug)
Part A (SAD): Dose A2
Single dose A2 of ACT-1014-6470; soft capsule for oral use.
干预措施: ACT-1014-6470 (SAD) (Drug)
Part A (SAD): Dose A2
Single dose A2 of ACT-1014-6470; soft capsule for oral use.
干预措施: Placebo (SAD) (Drug)
Part A (SAD): Dose A3
Single dose A3 of ACT-1014-6470 under fasted and fed conditions, separated by at least 18 days; soft capsule for oral use.
干预措施: ACT-1014-6470 (SAD) (Drug)
Part A (SAD): Dose A3
Single dose A3 of ACT-1014-6470 under fasted and fed conditions, separated by at least 18 days; soft capsule for oral use.
干预措施: Placebo (SAD) (Drug)
Part A (SAD): Dose A4
Single dose A4 of ACT-1014-6470; soft capsule for oral use.
干预措施: ACT-1014-6470 (SAD) (Drug)
Part A (SAD): Dose A4
Single dose A4 of ACT-1014-6470; soft capsule for oral use.
干预措施: Placebo (SAD) (Drug)
Part A (SAD): Dose A4
Single dose A4 of ACT-1014-6470; soft capsule for oral use.
干预措施: 14C-ACT-1014-6470 microtracer (Drug)
Part A (SAD): Dose A4
Single dose A4 of ACT-1014-6470; soft capsule for oral use.
干预措施: 14C-ACT-1014-6470 microtracer placebo (Drug)
Part A (SAD): Dose A5
Single dose A5 of ACT-1014-6470; soft capsule for oral use.
干预措施: Placebo (SAD) (Drug)
Part A (SAD): Dose A6
Single dose A6 of ACT-1014-6470; soft capsule for oral use.
干预措施: ACT-1014-6470 (SAD) (Drug)
Part A (SAD): Dose A6
Single dose A6 of ACT-1014-6470; soft capsule for oral use.
干预措施: Placebo (SAD) (Drug)
Part B (MAD): Dose B1
Multiple doses B1 of ACT-1014-6470; soft capsules for oral use.
干预措施: ACT-1014-6470 (MAD) (Drug)
Part B (MAD): Dose B1
Multiple doses B1 of ACT-1014-6470; soft capsules for oral use.
干预措施: Placebo (MAD) (Drug)
Part B (MAD): Dose B2
Multiple doses B2 of ACT-1014-6470; soft capsules for oral use.
干预措施: ACT-1014-6470 (MAD) (Drug)
Part B (MAD): Dose B2
Multiple doses B2 of ACT-1014-6470; soft capsules for oral use.
干预措施: Placebo (MAD) (Drug)
Part B (MAD): Dose B3
Multiple doses B3 of ACT-1014-6470; soft capsules for oral use.
干预措施: ACT-1014-6470 (MAD) (Drug)
Part B (MAD): Dose B3
Multiple doses B3 of ACT-1014-6470; soft capsules for oral use.
干预措施: Placebo (MAD) (Drug)
Part B (MAD): Dose B4
Multiple doses B4 of ACT-1014-6470; soft capsules for oral use.
干预措施: ACT-1014-6470 (MAD) (Drug)
Part B (MAD): Dose B4
Multiple doses B4 of ACT-1014-6470; soft capsules for oral use.
干预措施: Placebo (MAD) (Drug)
结局指标
主要结局
All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)
时间窗: Total duration of assessments: up to 3 weeks.
Blood samples for determination of PK parameters will be collected at predefined time points from Day 1 to Day 4 of Part A (SAD, Day 1 to Day 8 for ADME cohort A4) and from Day 1 to Day X+3 of Part B (MAD, with Day X = day of last study treatment administration).
次要结局
未报告次要终点