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
1 other identifier
interventional
67
1 country
1
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.
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 May 2016
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
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedApril 3, 2019
April 1, 2019
6 months
May 31, 2016
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Treatment Emergent Adverse Event
47 Days
Maximum observed plasma concentration [Cmax]
Maximum observed Plasma Concentration
47 Days
Area under the plasma concentration time curve during a dosing interval [AUC]
Area under the plasma concentration time curve during a dosing interval
47 Days
Time of maximum observed plasma concentration [Tmax]
Time of maximum observed plasma concentration
47 Days
Blood Pressure
47 Days
Study Arms (2)
IW-1701
EXPERIMENTALIW-1701 tablets administered orally in multiple ascending dose.
Placebo
PLACEBO COMPARATORMatching placebo tablets administered orally.
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 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
You may not qualify if:
- History of any clinically significant medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON Early Phase Unit
San Antonio, Texas, 78209, United States
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
May 31, 2016
First Posted
June 8, 2016
Study Start
May 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
April 3, 2019
Record last verified: 2019-04