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Completed

NCT Number: NCT01040637

A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients 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).

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Key information

Conditions

Healthy Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Research Unit, Pasadena, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-1211

Drug

Dose level 1

Placebo

Drug

Ascending doses

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Glycyx Therapeutics

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 29, 2009
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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