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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Matching Placebo Tablet; Drug: IW-1973

• Registration Number: NCT02616861
• Lead Sponsor: Cyclerion Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-29
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Matching Placebo Tablet	Matching Placebo
IW-1973	IW-1973	1973 Escalating Doses

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	42 Days
Maximum observed plasma concentration (Cmax)	42 Days
Area under the plasma concentration time curve during a dosing interval (AUC)	42 Days
Time of maximum observed plasma concentration (Tmax)	42 Days
Heart rate	42 Days
Serum cGMP	42 Days
Blood Pressure	42 days

Trial Locations

Locations (1)

Ironwood Investigator; 🇺🇸 San Antonio, Texas, United States