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Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia

NCT02931565 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-05-04

Study results available
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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

  • Achalasia

Interventions

DRUG

Olinciguat

oral tablet

DRUG

Matching Placebo

oral tablet

Sponsors & Collaborators

  • Cyclerion Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2018-05-01
Completion
2018-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931565 on ClinicalTrials.gov