inflammatory diseases inflammatory diseases
Conditions
Interventions
ACT-1014-6470 or placebo will be given once (multiple administrations in part
B) in the morning as oral capsule(s). In Group A4, ACT-1014-6470 (or placebo)
and 14C-ACT-1014-6470 (or placebo) will be
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A (SAD) All cohorts under fed conditions - Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf) | — |
Secondary
| Measure | Time frame |
|---|---|
| All cohorts under fed conditions - Maximum plasma concentration (Cmax). - Time to reach Cmax (tmax). - t*. Food effect evaluation only - AUC0-inf under fasted conditions. - Cmax under fasted conditions. - tmax under fasted conditions. - t* under fasted conditions. PART B (MAD) - AUC during a dosing interval (AUCtau) following the first and the last dose. Safety - Treatment-emergent adverse events (AEs) from the start of the study treatment administration up to End-of-Study (EOS) or End-of-Period (EOP). - Treatment-emergent serious AEs from the start of the study treatment administration up to EOS or EOP. | — |
Countries
Netherlands
Outcome results
None listed