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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02792998

Enrollment

Registered

2016-06-08

Start date

2016-05-31

Completion date

2016-11-30

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGIW-1701

IW-1701 Tablet

DRUGPlacebo

Matching Placebo Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Time of maximum observed plasma concentration [Tmax]	47 Days	Time of maximum observed plasma concentration
Blood Pressure	47 Days	—
Treatment Emergent Adverse Event	47 Days	—
Maximum observed plasma concentration [Cmax]	47 Days	Maximum observed Plasma Concentration
Area under the plasma concentration time curve during a dosing interval [AUC]	47 Days	Area under the plasma concentration time curve during a dosing interval

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026