A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
Primary Purpose
Healthy, Opioid-induced Constipation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-1211
TD-1211
TD-1211
TD-1211
TD-1211
TD-1211
TD-1211
TD-1211
TD-1211
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy subjects
Eligibility 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
Sites / Locations
- Clinical Research Unit
- Clinical Research Unit
- Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
TD-1211 dose level 1
TD-1211 dose level 2
TD-1211 dose level 3
TD-1211 dose level 4
TD-1211 OIC dose level 1
TD-1211 OIC dose level 2
TD-1211 OIC dose level 3
TD-1211 OIC dose level 4
TD-1211 OIC dose level 5
Placebo
Arm Description
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Ascending doses
Outcomes
Primary Outcome Measures
Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation
Secondary Outcome Measures
Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration
Full Information
NCT ID
NCT01040637
First Posted
December 22, 2009
Last Updated
January 15, 2021
Sponsor
Theravance Biopharma
1. Study Identification
Unique Protocol Identification Number
NCT01040637
Brief Title
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Opioid-induced Constipation
Keywords
Healthy subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD-1211 dose level 1
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 dose level 2
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 dose level 3
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 dose level 4
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 OIC dose level 1
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 OIC dose level 2
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 OIC dose level 3
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 OIC dose level 4
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
TD-1211 OIC dose level 5
Arm Type
Experimental
Arm Description
Ascending doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ascending doses
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Dose level 1
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Dose level 2
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Dose level 3
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Dose Level 4
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Ascending doses
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Ascending doses
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Ascending doses
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Ascending doses
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Ascending doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ascending doses
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Unit
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Clinical Research Unit
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Clinical Research Unit
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
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