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

2016-09-29 23:08:21 | BioPortfolio

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.

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Conditions

Healthy Subjects

Intervention

ACT-541468 (Formulation A), ACT-541468 (Formulation B), Placebo (Formulation A), Placebo (Formulation B), 14C-labeled ACT-541468, Placebo tracer

Location

Investigator Site
Leiden
Netherlands
2333 CL

Status

Completed

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-29T23:08:21-0400

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