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

Cyclerion Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Achalasia

Treatments: Drug: Matching Placebo; Drug: Olinciguat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02931565

C1701-201

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Other inclusion and exclusion criteria specified in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups, including a placebo group

IW-1701

Experimental group

Description:

Single 5-mg dose of IW-1701 administered orally

Treatment:

Drug: Olinciguat

Placebo

Placebo Comparator group

Description:

Matching placebo administered orally

Treatment:

Drug: Matching Placebo