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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/5/2019
Start Date:November 2015
End Date:June 2016

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Trial Summary
Trial Overview
Inclusion Criteria

A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage

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.


Inclusion Criteria:

- Subject is an ambulatory male or female between 18 and 55 years old at the Screening
Visit

- Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the Screening Visit

- Women of childbearing potential must have a negative pregnancy test and must agree to
use double-barrier contraception

- Subject is in good health and has no clinically significant findings on a physical
examination

- Other inclusion criteria per protocol

Exclusion Criteria:

- History of any clinically significant medical condition

- Other exclusion criteria per protocol
We found this trial at
1
site
Ironwood Investigational Site
San Antonio, Texas 78209
Phone: 210-798-5106
?
mi
from
San Antonio, TX
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