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Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

Last updated on October 10, 2019

FOR MORE INFORMATION
Study Location
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Ages of 18 and 45 years, inclusive.

2. Body mass index (BMI) of >= 17.5 and

3. 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

1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic
disease or clinical findings.

NCT03448172
Pfizer
Not yet recruiting
Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

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Descriptive Information
Brief Title  ICMJE Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects
Official Title  ICMJE A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects
Brief SummaryThe purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: [14C]PF-05221304
a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)
Study Arms  ICMJE Experimental: Investigational Product
[14C]PF-05221304
Intervention: Drug: [14C]PF-05221304
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: February 21, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 13, 2018
Actual Primary Completion DateMay 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ages of 18 and 45 years, inclusive.
  2. Body mass index (BMI) of >= 17.5 and <= 30.4 kg/m2
  3. Total body weight > 50 kg (110 lb).

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448172
Other Study ID Numbers  ICMJE C1171010
Has Data Monitoring CommitteeNo
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: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...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 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:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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