Trial record 1 of 1 for:
NCT01448395
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
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ClinicalTrials.gov Identifier: NCT01448395 |
Recruitment Status :
Completed
First Posted : October 7, 2011
Last Update Posted : September 1, 2017
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
Tracking Information | ||||
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First Submitted Date ICMJE | September 30, 2011 | |||
First Posted Date ICMJE | October 7, 2011 | |||
Last Update Posted Date | September 1, 2017 | |||
Study Start Date ICMJE | October 2011 | |||
Actual Primary Completion Date | November 2011 (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 | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104 | |||
Official Title ICMJE | An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104 | |||
Brief Summary | A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream. | |||
Detailed Description | An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite profile and Metabolite Identification of [14C]NXL104. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: [14C]NXL104
500mg/100mL intravenous solution
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Study Arms ICMJE | Experimental: 1
Intervention: Drug: [14C]NXL104
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
6 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2011 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01448395 | |||
Other Study ID Numbers ICMJE | D4280C00008 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |