Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2019-02-21

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Male Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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2-period, fixed sequence

fixed sequence with 2 treatment period

Group Type EXPERIMENTAL

Oral PF-06700841 containing 14C microtracer

Intervention Type DRUG

Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period

Oral unlabeled PF-06700841

Intervention Type DRUG

60 mg unlabeled PF-06700841 oral dose in 2nd period

IV 14C-labeled PF-06700841

Intervention Type DRUG

30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

Interventions

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Oral PF-06700841 containing 14C microtracer

Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period

Intervention Type DRUG

Oral unlabeled PF-06700841

60 mg unlabeled PF-06700841 oral dose in 2nd period

Intervention Type DRUG

IV 14C-labeled PF-06700841

30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes