drugset
drugset / Trial / NCT02099071

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

NCT02099071 ↗

Phase 1 Completed 65 enrolled Idorsia Pharmaceuticals Ltd.
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2011-11
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ACT-389949 Unknown 1 mg Oral
Subject ACT-389949 Unknown 5 mg Oral
Subject ACT-389949 Unknown 20 mg Oral
Subject ACT-389949 Unknown 50 mg Oral
Subject ACT-389949 Unknown 100 mg Oral
Subject ACT-389949 Unknown 200 mg Oral
Subject ACT-389949 Unknown 500 mg Oral
Subject ACT-389949 Unknown 1000 mg Oral

Indications

No indication recorded.