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

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NCT03448172

Last updated on July 17, 2018
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FOR MORE INFORMATION
Study Location
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
Completed
Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

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[email protected]

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Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects
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
The 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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: [14C]PF-05221304
a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)
Experimental: Investigational Product
[14C]PF-05221304
Intervention: Drug: [14C]PF-05221304
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
May 18, 2018
April 25, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 45 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03448172
C1171010
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
March 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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