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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Healthy, Opioid-induced Constipation

In brief

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).

Key facts

Study ID

NCT01040637

Run by

Glycyx Therapeutics

People needed

102

Starts

2010-01-01

Expected to finish

2010-10-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Unit — Pasadena, California, United States
• Clinical Research Unit — San Antonio, Texas, United States
• Clinical Research Unit — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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