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

NCT02919319 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clemens Muehlan · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2015-05-01
Completion
2015-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919319 on ClinicalTrials.gov