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

Pfizer6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]PF-05221304DRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Mass Balance

Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered

Time frame: 0-96 hr

Secondary Outcomes

Metabolic profiling for PF-05221304 in plasma, urine, and feces

Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces

Time frame: 0-96 hr

Radioactivity AUClast

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity

Time frame: 0-96 hr

Plasma PF-05221304 AUClast

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304

Time frame: 0-96 hr

Radioactivity AUCinf

Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for radioactivity

Time frame: 0-96 hr

Plasma PF-05221304 AUCinf

Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for PF-05221304

Time frame: 0-96 hr

Radioactivity Cmax

Maximum Observed Plasma Concentration (Cmax) for radioactivity

Time frame: 0-96 hr

Plasma PF-05221304 Cmax

Maximum Observed Plasma Concentration (Cmax) for PF-05221304

Data from ClinicalTrials.gov

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Number of subjects experiencing an adverse event

Assessment by physical examinations, adverse event monitoring, clinical laboratory measurements, vital signs and ECG. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity. Treatment-emergent are events between dosing with study drug and up to 28 days after that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

Time frame: Up to 28 days post dosing of IP on Day 1