NCT02919319 - A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 1, 2015

Primary Completion Date

May 1, 2015

Study Completion Date

May 1, 2015

Conditions

Healthy Subjects

Interventions

DRUG

ACT-541468 (Formulation A)

Hard gelatin capsules for oral administration formulated at strengths of 5 mg, 25 mg and 100 mg

DRUG

ACT-541468 (Formulation B)

Soft gelatin capsules for oral administration formulated at the strength of 25 mg

DRUG

Placebo (Formulation A)

Hard capsules matching ACT-541468 Formulation A

DRUG

Placebo (Formulation B)

Soft capsules matching ACT-541468 Formulation B

DRUG

14C-labeled ACT-541468

Tracer at a nominal dose of 250 nCi (corresponding to 2.02 µg ACT-541468) administered either orally or intravenously

DRUG

Placebo tracer

Sterile NaCl 0.9% was used as placebo matching the tracer for oral and i.v. administration.

Trial Locations (1)

Investigator Site, Leiden