NCT02099071

Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949

Single-center, Double-blind, Randomized, Placebo-controlled, Single-ascending Dose and Food Interaction Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending single oral dose and food interaction Phase 1 study. It will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of ACT-389949 in healthy male subjects. It will also investigate the effect of food on the pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ACT-389949 1 mg
DRUG	ACT-389949 5 mg
DRUG	ACT-389949 20 mg
DRUG	ACT-389949 50 mg
DRUG	ACT-389949 100 mg
DRUG	ACT-389949 200 mg
DRUG	ACT-389949 500 mg
DRUG	ACT-389949 1000 mg
DRUG	Placebo

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2014-03-28
• Last updated: 2018-07-10

Locations

1 site across 1 country: Netherlands