A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects



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

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Trial Summary
Trial Overview
Inclusion Criteria

A 2-Stage Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Tablets in Healthy Subjects in a Double-blind, Placebo-controlled, Multiple-ascending-dose Stage and an Open-label, Single-dose, Crossover Food-effect Stage

The objectives of this study are:

Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic
(PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects
over 7 days of repeated dosing

Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets
administered orally to healthy subjects, in fed and fasted states, in an open-label,
single-dose, 2-period, 2-sequence crossover study.


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 at the time of
check-in and must agree to use double-barrier contraception throughout the duration of
the study

- 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 conditions

- Other exclusion criteria per protocol
We found this trial at
1
site
ICON Early Phase Unit
8307 Gault Lane
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
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