Healthy
Conditions
Brief summary
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
Interventions
DRUGACT-1014-6470 (SAD)
Single dose of ACT-1014-6470; soft capsules for oral use.
DRUGACT-1014-6470 (MAD)
Multiple doses of ACT-1014-6470; soft capsules for oral use.
DRUGPlacebo (SAD)
Single dose of matching placebo; soft capsules for oral use.
DRUGPlacebo (MAD)
Multiple doses of matching placebo; soft capsules for oral use.
DRUG14C-ACT-1014-6470 microtracer
Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
DRUG14C-ACT-1014-6470 microtracer placebo
Single dose of matching placebo; soft capsules for oral use.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Single-center, double-blind, randomized, placebo-controlled Phase 1 study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
General Inclusion 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. 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 -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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| All cohorts: Time to reach Cmax (tmax). | 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) |
| All cohorts: t½. | 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) |
| Food effect evaluation only: AUC0-inf under fasted conditions. | 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) |
| Food effect evaluation only: Cmax under fasted conditions. | 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) |
| All cohorts: Maximum plasma concentration (Cmax). | 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) |
| Food effect evaluation only: t½ under fasted conditions | 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) |
| Part B (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose. | 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 X+3 of Part B (MAD, with Day X = day of last study treatment administration) |
| Treatment-emergent adverse events (AEs) | Total duration of assessments: up to 3 weeks. | From start of 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. |
| Treatment-emergent serious adverse events (SAEs) | Total duration of assessments: up to 3 weeks. | From start of 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. |
| Food effect evaluation only: tmax under fasted conditions. | 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) |
Countries
Netherlands
Outcome results
None listed