A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.

NCT04866225

Last updated date
Study Location
Covance Global Clinical Pharmacology
Madison, Wisconsin, 53704, United States
Contact
1-800-718-1021

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]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Participants
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male participants, 18 to 60 years of age, inclusive, at the time of signing the informed consent document.

- Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests.

- Participants who are nonsmoking for at least 3 months at the time of signing the informed consent document.

- BMI of 17.5 to 30.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).


- History of irregular bowel movements including irritable bowel syndrome or frequent
episodes of diarrhea or constipation, defined by less than 1 bowel movement on average
per 2 days, or lactose intolerance.


- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,
HBsAg,or HCVAb. Hepatitis B vaccination is allowed.


- History of SARS-CoV-2 PCR or antibody (eg, IgG, IgM, etc) positive result would
necessitate accompanying history of asymptomatic state for at least 6 months prior to
screening.


- Use of prescription or nonprescription drugs.


- Previous administration with an unapproved drug within 60 days preceding the first
dose of study intervention used in this study.


- A positive urine drug test.


- A positive urine cotinine test.


- A positive COVID-19 (SARS-CoV-2) PCR test.


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Healthy ParticipantsBioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)
NCT04856293
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy ParticipantsSTUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
NCT04756531
  1. Brussels, Bruxelles-capitale, Région DE
  2. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.
Official Title  ICMJE A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE EXTENT OF EXCRETION, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06865571 USING A 14C-MICROTRACER APPROACH
Brief Summary This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of [14C]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration of unlabeled PF-06865571 and IV administration of [14C]PF-06865571.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: Oral [14C]PF-06865571
    Oral radiolabeled PF-06865571
  • Drug: Oral PF-06865571
    Oral PF-06865571
  • Drug: IV [14C]PF-06865571
    IV radiolabeled PF-06865571
Study Arms  ICMJE Experimental: Study arm
One arm of healthy male participants administered a single oral dose of [14C]PF-06865571; followed by a single dose of unlabeled PF-06865571, and IV administration of [14C]PF-06865571 three hours later.
Interventions:
  • Drug: Oral [14C]PF-06865571
  • Drug: Oral PF-06865571
  • Drug: IV [14C]PF-06865571
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2021)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 13, 2021
Estimated Primary Completion Date July 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male participants, 18 to 60 years of age, inclusive, at the time of signing the informed consent document.
  • Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests.
  • Participants who are nonsmoking for at least 3 months at the time of signing the informed consent document.
  • BMI of 17.5 to 30.4 kg/m2, inclusive; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation, defined by less than 1 bowel movement on average per 2 days, or lactose intolerance.
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,or HCVAb. Hepatitis B vaccination is allowed.
  • History of SARS-CoV-2 PCR or antibody (eg, IgG, IgM, etc) positive result would necessitate accompanying history of asymptomatic state for at least 6 months prior to screening.
  • Use of prescription or nonprescription drugs.
  • Previous administration with an unapproved drug within 60 days preceding the first dose of study intervention used in this study.
  • A positive urine drug test.
  • A positive urine cotinine test.
  • A positive COVID-19 (SARS-CoV-2) PCR test.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04866225
Other Study ID Numbers  ICMJE C2541007
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
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 April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP