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

Last updated on January 10, 2019

FOR MORE INFORMATION
Study Location
PRA Health Sciences
Groningen, , 9728 NZ Netherlands
Contact
1-800-718-1021
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
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
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 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.

NCT03770039
Pfizer
Recruiting
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

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Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
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
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Male Subjects
  • 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
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
6
Same as current
February 27, 2019
February 27, 2019   (Final data collection date for primary outcome measure)

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 tobacco /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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03770039
B7931014
2018-002403-34 ( EudraCT Number )
No
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
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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