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

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	4/5/2019
Start Date:	February 2016
End Date:	May 1, 2018

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

The objectives of this study are as follows:

In patients with primary Type I or II Achalasia, following a single 5-mg dose of 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, Cmax, Tmax, and AUClast

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 GI motility in the 72 hours before Check-in
through Discharge from the clinic.

- Other exclusion criteria specified in the protocol.

We found this trial at

sites

Vanderbilt University Medical Center

1211 Medical Center Dr
Nashville, Tennessee 37232

(615) 322-5000