drugset / Trial / NCT01900184

Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects

NCT01900184

Phase 1 Completed 69 enrolled Quantum Genomics SA
RandomizedParallel-groupTriple-blind

Summary

1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (SAD \& MAD) in healthy young subjects, the preliminary food interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic preliminary profiles of QGC001 and its metabolite EC33 especially effects on the renin-angiotensin-aldosterone and copeptin systems.

Timeline

Start
2012-12
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Firibastat Small molecule 500 mg Oral
Subject Firibastat Small molecule 750 mg Oral
Subject Firibastat Small molecule 1000 mg Oral