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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Theravance Biopharma; Theravance Biopharma R & D, Inc.

Criteria

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