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

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NCT03770039

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Study Location
PRA Health Sciences
Groningen, , 9728 NZ, Netherlands
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Male Subjects
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Healthy Male SubjectsSingle Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects NCT03770039
  1. Groningen,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Drug: 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
  • Drug: Oral unlabeled PF-06700841
    60 mg unlabeled PF-06700841 oral dose in 2nd period
  • Drug: IV 14C-labeled PF-06700841
    30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
Study Arms  ICMJE Experimental: 2-period, fixed sequence
fixed sequence with 2 treatment period
Interventions:
  • Drug: Oral PF-06700841 containing 14C microtracer
  • Drug: Oral unlabeled PF-06700841
  • Drug: IV 14C-labeled PF-06700841
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
 (submitted: December 6, 2018)		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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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