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

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyclerion Therapeutics; Ironwood Pharmaceuticals, Inc.

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.