A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography Scanning

Pfizer8 enrolled

Overview

In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. The study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[11C]PF-06427878DRUG

Single administration via intravenous infusion of 20 ug \[11C\]PF-06427878 on Day 1 of all 3 Periods

PF-06427878 10 mgDRUG

Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to \[11C\]PF-06427878 administration

PF-06427878 600 mgDRUG

Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to \[11C\]PF-06427878 administration

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy males * body mass index 17.5-30.5 kg/m2 ; body weight \>50 kg * signed and dated informed consent document * willing and able to comply with study requirements Exclusion Criteria: * tobacco/nicotine containing products \> equivalent of 5 cigarettes per day * history of cumulative ionizing radiation exposure in the past year, including anticipated exposure in this study, and subjects with current, past or anticipated exposure to radiation in the workplace * severe claustrophobia * unable to lie still for the required period to acquire images

Locations (3)

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Anylan Center

New Haven, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Percent injected radioactivity (per gram) over time in the liver

Time frame: All Periods;Day 1;0-120min

Percent injected radioactivity (per gram) over time in the plasma

Time frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min

Secondary Outcomes

Relative radioactivity in liver versus plasma

Ratio of AUC of percent injected radioactivity (per gram) over time in liver to AUC of percent injected radioactivity (per gram) over time in plasma

Time frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min

Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable

Time frame: All Periods;Day 1;0-2hr

% of parent in plasma over time

Parent is study drug PF-06427878

Time frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min

Plasma PK of PF-06427878: AUClast, as data permit

Time frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min

Plasma PK of PF-06427878: AUClast, as data permit.

Time frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min

Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the biliary tree, if this region is identifiable

Time frame: All Periods;Day 1;0-2hr

Data from ClinicalTrials.gov

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