Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects
NCT03448172
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Adult Trials: 18+ Years
1. Ages of 18 and 45 years, inclusive.
2. Body mass index (BMI) of >= 17.5 and <= 30.4 kg/m2
3. Total body weight > 50 kg (110 lb).
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic
disease or clinical findings.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects | ||||
| Official Title ICMJE | A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects | ||||
| Brief Summary | The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects | ||||
| Detailed Description | Not Provided | ||||
| 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 | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: [14C]PF-05221304
a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation) | ||||
| Study Arms ICMJE | Experimental: Investigational Product
[14C]PF-05221304 Intervention: Drug: [14C]PF-05221304 | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 6 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 13, 2018 | ||||
| Actual Primary Completion Date | May 26, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings. | ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03448172 | ||||
| Other Study ID Numbers ICMJE | C1171010 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | December 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||