drugset / Trial / NCT01900171

Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

NCT01900171

Phase 1 Completed 56 enrolled Quantum Genomics SA
RandomizedParallel-groupTriple-blind

Summary

QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.

Timeline

Start
2012-02
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Firibastat Small molecule 10 mg Oral
Subject Firibastat Small molecule 50 mg Oral
Subject Firibastat Small molecule 125 mg Oral
Subject Firibastat Small molecule 250 mg Oral
Subject Firibastat Small molecule 500 mg Oral
Subject Firibastat Small molecule 750 mg Oral
Subject Firibastat Small molecule 1000 mg Oral
Subject Firibastat Small molecule 1250 mg Oral