A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo (Food-effect subpart); Other: Placebo; Drug: ACT-1004-1239 (Food-effect subpart); Drug: ACT-1004-1239

• Registration Number: NCT03869320
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-03-25
• Primary Completion: 2019-07-11
• Study Completion: 2019-07-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
• Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
• No sperm donation from (first) study treatment administration up to at least 90 days after (last) study treatment administration.
• Sexual abstinence or use of condoms from (first) treatment administration up to at least 90 days after (last) study treatment administration. Moreover, the female partner of childbearing potential must use a highly effective method of contraception.

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.
• Any previous and/or ongoing relevant immune-related disorder or any evidence for immune dysfunction based on medical history and laboratory tests at Screening
• Any cardiac condition or illness (including clinically relevant 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on medical history and 12-lead ECG measured at Screening.
• QT interval corrected with Fridericia's formula (QTcF) > 430 ms, respectively, QRS interval > 110 ms, PR interval > 200 ms, or heart rate (HR) > 90 bpm on 12-lead ECG at Screening and Day 1 pre-dose (of the first period when applicable).
• Treatment with another investigational treatment within the 2 months prior to Screening or participation in more than 3 investigational treatment studies within the year prior to Screening.
• History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the ADME of the study treatment (e.g., appendectomy and herniotomy allowed, cholecystectomy not allowed).
• Previous treatment with any prescribed medications (including vaccines and strong CYP3A4 inhibitors/inducers) or over-the-counter (OTC) medications (including homeopathic preparations, herbal medicines, vitamins, and minerals) within the 2 weeks or 5 terminal half-lives (t½; whichever is longer) prior to (first) study treatment administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food-effect subpart: Placebo	Placebo (Food-effect subpart)	Matching placebo will be given under both fasted (first period) and fed (second period) conditions.
Placebo	Placebo	Matching placebo will be given as a single oral dose under fasted conditions. Matching placebo for the oral and intravenous administration of the 14C-radiolabeled ACT-1004-1239 will also be available.
Food-effect subpart: ACT-1004-1239	ACT-1004-1239 (Food-effect subpart)	ACT-1004-1239 will be given under both fasted (first period) and fed (second period) conditions. The food effect will be evaluated after the first 3 cohorts have been performed.
ACT-1004-1239	ACT-1004-1239	ACT-1004-1239 will be given as a single oral dose under fasting conditions. Eight doses are planned with a starting dose of 1 mg. The ADME characteristics and absolute bioavailability using a 14C-radiolabeled microtracer will be evaluated as part of the SAD, after the first 3 cohorts have been performed.

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment-emergent (serious) adverse events (AEs and SAEs)	From baseline up to EOS of each cohort (total duration: up to 6 weeks)

Trial Locations

Locations (1)

Pharmaron CPC, Inc. & Affiliates; 🇺🇸 Baltimore, Maryland, United States