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

Phase 1

Completed

• Conditions: Opioid-induced Constipation; Healthy
• Interventions: Drug: TD-1211; Drug: Placebo

• Registration Number: NCT01040637
• Lead Sponsor: Theravance Biopharma

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-29
• Study Start: 2010-01
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Disposition First Submitted: 2013-02-08
• Disposition First Submitted QC: 2013-02-13
• Disposition First Posted: 2013-02-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-1211 dose level 1	TD-1211	Ascending doses
TD-1211 dose level 4	TD-1211	Ascending doses
TD-1211 OIC dose level 4	TD-1211	Ascending doses
TD-1211 OIC dose level 5	TD-1211	Ascending doses
Placebo	Placebo	Ascending doses
TD-1211 dose level 3	TD-1211	Ascending doses
TD-1211 OIC dose level 1	TD-1211	Ascending doses
TD-1211 OIC dose level 3	TD-1211	Ascending doses
TD-1211 dose level 2	TD-1211	Ascending doses
TD-1211 OIC dose level 2	TD-1211	Ascending doses

Primary Outcome Measures

Name	Time	Method
Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation	Daily pre and post dose assessments throughout the duration of the study period

Secondary Outcome Measures

Name	Time	Method
Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration	Daily pre and post dose assessments throughout the duration of the study period

Trial Locations

Locations (1)

Clinical Research Unit; 🇺🇸 Salt Lake City, Utah, United States