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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IW-1701; Drug: Placebo

• Registration Number: NCT02792998
• Lead Sponsor: Cyclerion Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IW-1701	IW-1701	IW-1701 tablets administered orally in multiple ascending dose.
Placebo	Placebo	Matching placebo tablets administered orally.

Primary Outcome Measures

Name	Time	Method
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
Time of maximum observed plasma concentration [Tmax]	47 Days	Time of maximum observed plasma concentration
Blood Pressure	47 Days

Trial Locations

Locations (1)

ICON Early Phase Unit; 🇺🇸 San Antonio, Texas, United States