drugset / Trial / NCT02616861

Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

NCT02616861 ↗

Phase 1 Completed 54 enrolled Cyclerion Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study. Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.

Timeline

Start
2015-11
Primary completion
2016-05
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Praliciguat Small molecule — Oral

Indications

No indication recorded.