drugset / Trial / NCT03155503

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects

NCT03155503 ↗

Phase 1 Completed 64 enrolled Suven Life Sciences Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.

Timeline

Start
2017-05-22
Primary completion
2018-03-07
Completion
2018-03-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ropanicant Small molecule 0.5 mg Oral
Comparator Ropanicant Small molecule 6 mg Oral
Comparator Ropanicant Small molecule 15 mg Oral
Comparator Ropanicant Small molecule 30 mg Oral
Comparator Ropanicant Small molecule 45 mg Oral
Comparator Ropanicant Small molecule 60 mg Oral