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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT01040637
First received: December 22, 2009
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Healthy
Opioid-induced Constipation
 Drug: TD-1211
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Theravance, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TD-1211 dose level 1
Ascending doses
 Drug: TD-1211
Dose level 1
Experimental: TD-1211 dose level 2
Ascending doses
 Drug: TD-1211
Dose level 2
Experimental: TD-1211 dose level 3
Ascending doses
 Drug: TD-1211
Dose level 3
Experimental: TD-1211 dose level 4
Ascending doses
 Drug: TD-1211
Dose Level 4
Experimental: TD-1211 OIC dose level 1
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose level 2
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose leve 3
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose level 4
Ascending doses
 Drug: TD-1211
Ascending doses
Experimental: TD-1211 OIC dose level 5
Ascending doses
 Drug: TD-1211
Ascending doses
Placebo Comparator: Placebo
Ascending doses
 Drug: Placebo
Ascending doses

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040637

Locations
United States, California
Clinical Research Unit
Pasadena, California, United States, 91105
United States, Texas
Clinical Research Unit
San Antonio, Texas, United States, 78209
United States, Utah
Clinical Research Unit
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Theravance, Inc.
  More Information

No publications provided

Responsible Party: Theravance, Inc.
ClinicalTrials.gov Identifier: NCT01040637     History of Changes
Other Study ID Numbers: 0067
Study First Received: December 22, 2009
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:
Healthy subjects

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013