NCT02919319

A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects

Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics, Absolute Bioavailability, Mass Balance, and Metabolism of ACT-541468 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults. Pharmacodynamic effects (through a battery of Central Nervous System tests) were also assessed.

Detailed description

The study consisted of ascending dose groups; each dose group was investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo). In addition, the study included a biocomparison part (dose group 2), an absolute bioavailability part (dose group 4), and a mass balance / metabolism part (dose group 3).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2016-09-29
• Last updated: 2018-07-10

Locations

1 site across 1 country: Netherlands