Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
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
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2015
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 3, 2019
April 1, 2019
6 months
October 29, 2015
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (7)
Treatment Emergent Adverse Events
42 Days
Maximum observed plasma concentration (Cmax)
42 Days
Blood Pressure
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
Study Arms (2)
IW-1973
EXPERIMENTAL1973 Escalating Doses
Placebo
PLACEBO COMPARATORMatching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of any clinically significant medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ironwood Investigator
San Antonio, Texas, 78209, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
John Hanrahan, MD
Ironwood Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2015
First Posted
November 30, 2015
Study Start
November 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
April 3, 2019
Record last verified: 2019-04