CompletedPhase 1/2

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

United States102 participantsStarted 2010-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation

Timeframe: Daily pre and post dose assessments throughout the duration of the study period

Trial details

NCT IDNCT01040637

SponsorTheravance Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

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