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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 March 25, 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
Not yet recruiting
Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects

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Pfizer Clinical Trials Contact Center

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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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