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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

July 11, 2019

Study Completion Date

July 11, 2019

Conditions
Healthy
Interventions
DRUG

ACT-1004-1239

ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg. For the ADME subpart, a single oral dose of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given simultaneously with the ACT-1004-1239 capsule. For the absolute bioavailability subpart, a single intravenous dose of a maximum of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given at the expected tmax after the administration of the ACT-1004-1239 capsule.

OTHER

Placebo

Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.

DRUG

ACT-1004-1239 (Food-effect subpart)

ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg.

OTHER

Placebo (Food-effect subpart)

Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.

Trial Locations (1)

21201

Pharmaron CPC, Inc. & Affiliates, Baltimore

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY

NCT03869320 - A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects | Biotech Hunter | Biotech Hunter