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NCT01040637 Clinical Trial

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

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01040637
Other study ID # 0067
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2010
Est. completion date October 2010

Study information
Verified date January 2021
Source Theravance Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• TD-1211
Dose level 1
• TD-1211
Dose level 2
• TD-1211
Dose level 3
• TD-1211
Dose Level 4
• TD-1211
Ascending doses
• TD-1211
Ascending doses
• TD-1211
Ascending doses
• TD-1211
Ascending doses
• TD-1211
Ascending doses
• Placebo
Ascending doses

Locations
Country Name City State
United States Clinical Research Unit Pasadena California
United States Clinical Research Unit Salt Lake City Utah
United States Clinical Research Unit San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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