Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
NCT03770039
ABOUT THIS STUDY
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- Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
- Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
- History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON®-TB Gold test
- Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine
cotinine test
- Use of herbal supplements within 28 days prior to the first dose of study medication
- Use of prescription or nonprescription drugs (including vitamins and dietary
supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first
dose of study medication. As an exception, acetaminophen may be used at doses of 1
g/day. Limited use of non-prescription medications that are not believed to affect
subject safety or the overall results of the study may be permitted on a case-by-case
basis following approval by Pfizer
- Inability to have at least one bowel movement every 2 days on average eGFR of <90
mL/mim/1.73 m2 based on MDRD equation
- Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to
the first dose of investigational product, or expects to be vaccinated with these
vaccines during study treatment, or within the 6 weeks following the last dose of
investigational product.
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Descriptive Information | |||||||
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Brief Title ICMJE | Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects | ||||||
Official Title ICMJE | A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH | ||||||
Brief Summary | An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||||
Condition ICMJE | Healthy Male Subjects | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 2-period, fixed sequence
fixed sequence with 2 treatment period Interventions:
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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. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 6 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | February 21, 2019 | ||||||
Actual Primary Completion Date | February 21, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Netherlands | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03770039 | ||||||
Other Study ID Numbers ICMJE | B7931014 2018-002403-34 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |