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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01040637

Enrollment

102

Registered

2009-12-29

Start date

2010-01-01

Completion date

2010-10-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Opioid-induced Constipation

Keywords

Healthy subjects

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).

Interventions

DRUGTD-1211

Dose level 1

DRUGPlacebo

Ascending doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Contacts

STUDY_DIRECTORMedical Monitor

Theravance Biopharma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026