A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The Body

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C] PF-04449913

• Registration Number: NCT02110342
• Lead Sponsor: Pfizer

Brief Summary

The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Study Start: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy male subjects between the ages of 18 and 55 years (inclusive):Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
• A positive urine drug screen or urine cotinine test
• 12 lead ECG demonstrating QTc >450 or a QRS interval >120 msec msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and calcium at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	[14C] PF-04449913	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) for total radioactivity related to drug product	7 days
Radioactivity in blood	7 days	Total percentage of radioactivity in blood related to drug product
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] for total radioactivity related to drug product	7 days	AUC (0 - 8)= Area under the plasma radioactivity concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)	7 days
Urine PF-04449913 PK parameters	7 days	Measure of renal clearance (CLr), amount excreted unchanged in urine (Ae) and the fraction of dose excreted unchanged in urine (AE%)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	7 days	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Cumulative recovery of radioactivity in excreta	7 days	Total percentage of dosed radioactivity recovered in urine and feces

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	7 days	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Decay Half-Life (t1/2)	7 days	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)	7 days	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F)	7 days	plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Madison, Wisconsin, United States