A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT02792998|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : December 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: IW-1701 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
IW-1701 tablets administered orally in multiple ascending dose.
Placebo Comparator: Placebo
Matching placebo tablets administered orally.
Matching Placebo Tablet
- Treatment Emergent Adverse Event [ Time Frame: 47 Days ]
- Maximum observed plasma concentration [Cmax] [ Time Frame: 47 Days ]Maximum observed Plasma Concentration
- Area under the plasma concentration time curve during a dosing interval [AUC] [ Time Frame: 47 Days ]Area under the plasma concentration time curve during a dosing interval
- Time of maximum observed plasma concentration [Tmax] [ Time Frame: 47 Days ]Time of maximum observed plasma concentration
- Blood Pressure [ Time Frame: 47 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792998
|United States, Texas|
|ICON Early Phase Unit|
|San Antonio, Texas, United States, 78209|