Clinical trial NCT04183686: A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single-center, double-blind, randomized, placebo-controlled Phase 1 study
Primary purpose: OTHER

Brief summary: A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects


Eligibility 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.

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.

Primary outcomes:
measure: All cohorts: Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf)
timeFrame: Total duration of assessments: up to 3 weeks.
Secondary outcomes:
Other outcomes:
measure: All cohorts: Maximum plasma concentration (Cmax).
timeFrame: Total duration of assessments: up to 3 weeks.
measure: All cohorts: Time to reach Cmax (tmax).
timeFrame: Total duration of assessments: up to 3 weeks.
measure: All cohorts: t½.
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Food effect evaluation only: AUC0-inf under fasted conditions.
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Food effect evaluation only: Cmax under fasted conditions.
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Food effect evaluation only: tmax under fasted conditions.
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Food effect evaluation only: t½ under fasted conditions
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Part B (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose.
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Treatment-emergent adverse events (AEs)
timeFrame: Total duration of assessments: up to 3 weeks.
measure: Treatment-emergent serious adverse events (SAEs)
timeFrame: Total duration of assessments: up to 3 weeks.
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: