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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-06

Study Completion Date

2018-05-01

Brief Summary

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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

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Detailed Description

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Conditions

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Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IW-1701

Single 5-mg dose of IW-1701 administered orally

Group Type EXPERIMENTAL

Olinciguat

Intervention Type DRUG

oral tablet

Placebo

Matching placebo administered orally

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

oral tablet

Interventions

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Olinciguat

oral tablet

Intervention Type DRUG

Matching Placebo

oral tablet

Intervention Type DRUG

Other Intervention Names

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IW-1701

Eligibility Criteria

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Inclusion Criteria

* Patient has a diagnosis of primary Type I or II achalasia.
* Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion.

Exclusion Criteria

* Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent.
* More than 1 pneumatic dilation procedure to a diameter of \> 2 cm in their lifetime.
* Pneumatic dilation procedure to a diameter of \> 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.
* Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime.
* Patients with malignant or premalignant esophageal lesions.
* Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72 hours before check-in through discharge from the clinic.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No