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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]PF-05221304

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Product; [14C]PF-05221304	Drug: [14C]PF-05221304; a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-96 hr
Radioactivity AUClast	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity	0-96 hr
Plasma PF-05221304 AUClast	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304	0-96 hr
Radioactivity AUCinf	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for radioactivity	0-96 hr
Plasma PF-05221304 AUCinf	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304	0-96 hr
Radioactivity Cmax	Maximum Observed Plasma Concentration (Cmax) for radioactivity	0-96 hr
Plasma PF-05221304 Cmax	Maximum Observed Plasma Concentration (Cmax) for PF-05221304	0-96 hr
Radioactivity Tmax	Time to Reach Maximum Observed Plasma Concentration for radioactivity	0-96 hr
Plasma PF-05221304 Tmax	Time to Reach Maximum Observed Plasma Concentration for PF-05221304	0-96 hr
Radioactivity t1/2	Plasma Decay Half-Life (t1/2) for radioactivity	0-96 hr
Plasma PF-05221304 t1/2	Plasma Decay Half-Life (t1/2) for PF-05221304	0-96 hr
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.	Up to 28 days post dosing of IP on Day 1

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): May 26, 2018
• Study Completion (Actual): June 13, 2018

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: C1171010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No