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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]PF-05221304

• Registration Number: NCT03448172
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Study Start: 2018-04-18
• Primary Completion: 2018-05-26
• Study Completion: 2018-06-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Product	[14C]PF-05221304	\[14C\]PF-05221304

Primary Outcome Measures

Name	Time	Method
Mass Balance	0-96 hr	Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered

Secondary Outcome Measures

Name	Time	Method
Radioactivity Cmax	0-96 hr	Maximum Observed Plasma Concentration (Cmax) for radioactivity
Plasma PF-05221304 Tmax	0-96 hr	Time to Reach Maximum Observed Plasma Concentration for PF-05221304
Radioactivity t1/2	0-96 hr	Plasma Decay Half-Life (t1/2) for radioactivity
Number of subjects experiencing an adverse event	Up to 28 days post dosing of IP on Day 1	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.
Metabolic profiling for PF-05221304 in plasma, urine, and feces	0-96 hr	Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces
Radioactivity AUClast	0-96 hr	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity
Plasma PF-05221304 Cmax	0-96 hr	Maximum Observed Plasma Concentration (Cmax) for PF-05221304
Radioactivity Tmax	0-96 hr	Time to Reach Maximum Observed Plasma Concentration for radioactivity
Plasma PF-05221304 t1/2	0-96 hr	Plasma Decay Half-Life (t1/2) for PF-05221304
Plasma PF-05221304 AUClast	0-96 hr	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
Radioactivity AUCinf	0-96 hr	Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for radioactivity
Plasma PF-05221304 AUCinf	0-96 hr	Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for PF-05221304

Trial Locations

Locations (1)

Covance Clinical Research Unit Inc.; 🇺🇸 Madison, Wisconsin, United States