A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation



Status:Completed
Conditions:Constipation, Healthy Studies
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 65
Updated:1/31/2019
Start Date:January 2010
End Date:October 2010

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).


Inclusion Criteria:

- Males and females between 18 and 65 years of age, inclusive

- Healthy subjects and subjects with documented OIC on stable opioid regimen

- Willingness to stop all laxatives throughout the OIC screening and treatment period

Exclusion Criteria:

- Any clinically significant finding in healthy subjects

- Have participated in another clinical trial of an investigational drug 30 days prior
to screening

- History of chronic constipation prior to opioid therapy in OIC subjects

- Active medical disorders associated with diarrhea or intermittent loose stools in OIC
subjects
We found this trial at
3
sites
Clinical Research Unit
San Antonio, Texas 78209
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Clinical Research Unit
Pasadena, California 91105
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Pasadena, CA
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Clinical Research Unit
Salt Lake City, Utah 84106
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Salt Lake City, UT
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