Trials / Terminated
TerminatedNCT02931565
Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-dose, Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 in Patients With Achalasia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Cyclerion Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are as follows: In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701), * To assess the safety and tolerability * To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM) * To determine the pharmacokinetic (PK) parameters
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olinciguat | oral tablet |
| DRUG | Matching Placebo | oral tablet |
Timeline
- Start date
- 2017-04-06
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
- First posted
- 2016-10-13
- Last updated
- 2021-05-04
- Results posted
- 2021-05-04
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02931565. Inclusion in this directory is not an endorsement.