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
- Conditions
- inflammatory diseases
- Registration Number
- NL-OMON48421
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 88
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
allowed).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PART A (SAD)<br /><br>All cohorts under fed conditions<br /><br>- Area under the plasma concentration-time curve (AUC) from zero to infinity<br /><br>(AUC0-inf)</p><br>
- Secondary Outcome Measures
Name Time Method <p>All cohorts under fed conditions<br /><br>- Maximum plasma concentration (Cmax).<br /><br>- Time to reach Cmax (tmax).<br /><br>- t*.<br /><br>Food effect evaluation only<br /><br>- AUC0-inf under fasted conditions.<br /><br>- Cmax under fasted conditions.<br /><br>- tmax under fasted conditions.<br /><br>- t* under fasted conditions.<br /><br><br /><br>PART B (MAD)<br /><br>- AUC during a dosing interval (AUCtau) following the first and the last dose.<br /><br><br /><br>Safety<br /><br>- Treatment-emergent adverse events (AEs) from the start of the study treatment<br /><br>administration up to End-of-Study (EOS) or End-of-Period (EOP).<br /><br>- Treatment-emergent serious AEs from the start of the study treatment<br /><br>administration up to EOS or EOP. </p><br>