A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
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ClinicalTrials.gov Identifier: NCT01040637 |
Recruitment Status
:
Completed
First Posted
: December 29, 2009
Last Update Posted
: September 10, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Opioid-induced Constipation | Drug: TD-1211 Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040637
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 |
Responsible Party: | Theravance Biopharma R & D, Inc. |
ClinicalTrials.gov Identifier: | NCT01040637 History of Changes |
Other Study ID Numbers: |
0067 |
First Posted: | December 29, 2009 Key Record Dates |
Last Update Posted: | September 10, 2014 |
Last Verified: | September 2014 |
Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):
Healthy subjects |
Additional relevant MeSH terms:
Constipation Signs and Symptoms, Digestive Signs and Symptoms |