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

NCT ID: NCT03448172

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2018-06-13

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Investigational Product

\[14C\]PF-05221304

Group Type EXPERIMENTAL

[14C]PF-05221304

Intervention Type DRUG

a single oral dose of \[14C\]PF-05221304 (50 mg/100 µCi liquid formulation)

Interventions

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[14C]PF-05221304

a single oral dose of \[14C\]PF-05221304 (50 mg/100 µCi liquid formulation)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Covance Clinical Research Unit Inc.

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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C1171010

Identifier Type: -

Identifier Source: org_study_id

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