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

May 19, 2026 updated by: Glycyx Therapeutics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Pasadena, California, United States, 91105
    - Clinical Research Unit
- Texas
  - San Antonio, Texas, United States, 78209
    - Clinical Research Unit
- Utah
  - Salt Lake City, Utah, United States, 84106
    - Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TD-1211 dose level 1 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 dose level 2 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 dose level 3 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 dose level 4 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 OIC dose level 1 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 OIC dose level 2 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 OIC dose level 3 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 OIC dose level 4 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Experimental: TD-1211 OIC dose level 5 Ascending doses	Drug: TD-1211 Dose level 1 Drug: TD-1211 Dose level 2 Drug: TD-1211 Dose level 3 Drug: TD-1211 Dose Level 4 Drug: TD-1211 Ascending doses
Placebo Comparator: Placebo Ascending doses	Drug: Placebo Ascending doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration Time Frame: Daily pre and post dose assessments throughout the duration of the study period	Daily pre and post dose assessments throughout the duration of the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glycyx Therapeutics

Collaborators

Theravance Biopharma

Investigators

Study Director: Medical Monitor, Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimated)

December 29, 2009

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Healthy subjects

Additional Relevant MeSH Terms

Other Study ID Numbers

0067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on TD-1211

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