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 Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )

ClinicalTrials.gov Identifier:

NCT01040637

First received: December 22, 2009

Last updated: September 3, 2014

Last verified: September 2014

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 Biopharma Antibiotics, 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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Biopharma R & D, Inc.

More Information


Responsible Party:	Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier:	NCT01040637 History of Changes
Other Study ID Numbers:	0067
Study First Received:	December 22, 2009
Last Updated:	September 3, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:


Healthy subjects

Additional relevant MeSH terms:


Constipation Signs and Symptoms, Digestive Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016

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