Overview

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

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Criteria
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