TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
This study is not yet open for participant recruitment.
Verified July 2012 by Theravance
Sponsor:
Theravance
Information provided by (Responsible Party):
Theravance
ClinicalTrials.gov Identifier:
NCT01655771
First received: July 31, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
Tracking Information | |||||
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First Received Date ICMJE | July 31, 2012 | ||||
Last Updated Date | July 31, 2012 | ||||
Start Date ICMJE | August 2012 | ||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects | ||||
Official Title ICMJE | 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 | ||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Constipation | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 48 | ||||
Estimated Completion Date | October 2012 | ||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01655771 | ||||
Other Study ID Numbers ICMJE | 0083 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Theravance | ||||
Study Sponsor ICMJE | Theravance | ||||
Collaborators ICMJE | |||||
Investigators ICMJE | |||||
Information Provided By | Theravance | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |