A 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 - SAD, MAD, ADME of ACT-1014-6470 in healthy subjects

Idorsia Pharmaceuticals Ltd0 个研究点目标入组 88 人开始时间: 待定最近更新: 2024年4月15日

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试验速览

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•General criteria
•- 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.
•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 -1. 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 -1.

•General criteria
•- Pregnant or lactating women.
•- 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 (appendectomy and herniotomy allowed, cholecystectomy not
•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.

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