Back to resultsTD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
Primary Purpose
Constipation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-1211 Dose 1
TD-1211 Dose 2
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Opioid induced constipation, Constipation
Eligibility Criteria
Inclusion Criteria:
- For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive.
- Body mass index (BMI) should be 18 to 36 kg/m2, inclusive.
- At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supine systolic and diastolic blood pressure of 90 to 150 mm Hg and 50 to 90 mm Hg, respectively (2 of 3 measurements)
- Subjects with mild, chronic, stable disease (e.g., controlled hypertension, non-insulin-dependent diabetes, arthritis) may be enrolled if deemed medically acceptable by the investigator
- Negative for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus antibody within the last 3 months
- No clinically relevant abnormalities in laboratory evaluations
Exclusion Criteria:
- History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if condition is well controlled and not anticipated to interfere with the objectives of the study.
- Any clinically significant abnormal ECG (electrocardiogram).
- Participation in another clinical trial of an investigational drug or medical device within 60 days.
- Donation of ≥500 mL blood, or equivalent, within 8 weeks prior to admission day.
- Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety, tolerability, or PK of the investigational drug or prevent compliance with the study protocol.
Sites / Locations
- ICON Development Solutions
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Elderly
Younger
Arm Description
TD-1211 Dose 1
TD-1211 Dose 2
Outcomes
Primary Outcome Measures
Cmax
AUCt
AUCinf
Secondary Outcome Measures
Number of patients with treatment-emergent adverse events
Number patients with abnormal vital sign measurements
Number of patients with abnormal clinical laboratory results
Number of patients with abnormal corrected QTc interval
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01655771
Brief Title
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
Official Title
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of TD-1211 Administered Orally to Elderly and Young Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (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 measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Opioid induced constipation, Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderly
Arm Type
Experimental
Arm Description
TD-1211 Dose 1
Arm Title
Younger
Arm Type
Experimental
Arm Description
TD-1211 Dose 2
Intervention Type
Drug
Intervention Name(s)
TD-1211 Dose 1
Intervention Type
Drug
Intervention Name(s)
TD-1211 Dose 2
Primary Outcome Measure Information:
Title
Cmax
Time Frame
0-96 hours
Title
AUCt
Time Frame
Based on samples collected 0-96 hours
Title
AUCinf
Time Frame
Based on samples collected 0-96 hours
Secondary Outcome Measure Information:
Title
Number of patients with treatment-emergent adverse events
Time Frame
Days 1-14
Title
Number patients with abnormal vital sign measurements
Time Frame
Days 1-5
Title
Number of patients with abnormal clinical laboratory results
Time Frame
Days 1-5
Title
Number of patients with abnormal corrected QTc interval
Time Frame
Days 1-5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive.
Body mass index (BMI) should be 18 to 36 kg/m2, inclusive.
At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supine systolic and diastolic blood pressure of 90 to 150 mm Hg and 50 to 90 mm Hg, respectively (2 of 3 measurements)
Subjects with mild, chronic, stable disease (e.g., controlled hypertension, non-insulin-dependent diabetes, arthritis) may be enrolled if deemed medically acceptable by the investigator
Negative for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus antibody within the last 3 months
No clinically relevant abnormalities in laboratory evaluations
Exclusion Criteria:
History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if condition is well controlled and not anticipated to interfere with the objectives of the study.
Any clinically significant abnormal ECG (electrocardiogram).
Participation in another clinical trial of an investigational drug or medical device within 60 days.
Donation of ≥500 mL blood, or equivalent, within 8 weeks prior to admission day.
Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety, tolerability, or PK of the investigational drug or prevent compliance with the study protocol.
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
ICON Development Solutions
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
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TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
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