A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01406132
First received: June 30, 2011
Last updated: July 28, 2011
Last verified: July 2011
Tracking Information | |||||
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First Received Date ICMJE | June 30, 2011 | ||||
Last Updated Date | July 28, 2011 | ||||
Start Date ICMJE | December 2009 | ||||
Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pharmacokinetic assessment through radiographic and high performance liquid chromatography (HPLC) analysis of blood, urine and feces samples [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406132 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects | ||||
Official Title ICMJE | A Phase 1, Open-Label, Mass Balance Study to Evaluate the Pharmacokinetics of ASP015K After a Single Oral Dose of 14C-Labeled ASP015K in Healthy Male Subjects | ||||
Brief Summary | The objective of this study is to evaluate pharmacokinetics, in particular the routes of excretion and extent of metabolism of ASP015K after a single oral dose of 14C-labeled ASP015K. |
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Detailed Description | Eligible subjects will be admitted to the clinical research unit and confined for a minimum of 8 days. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
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Condition ICMJE |
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Intervention ICMJE | Drug: ASP015K
oral |
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Study Arm (s) | Experimental: ASP015K
Intervention: Drug: ASP015K |
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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 | Completed | ||||
Enrollment ICMJE | 6 | ||||
Completion Date | January 2010 | ||||
Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406132 | ||||
Other Study ID Numbers ICMJE | 015K-CL-PK03 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Clinical Trials Registry, Astellas Pharma Global Development | ||||
Study Sponsor ICMJE | Astellas Pharma Inc | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Astellas Pharma Inc | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |