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
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
5
sites
39 Brewster Road
Bristol, Connecticut 06010
Bristol, Connecticut 06010
Phone: 860-585-3838
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-4643
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Saint Louis, Missouri 63110
Phone: 314-747-5366
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30 North 1900 East
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
Phone: 801-581-8051
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