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
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 55
Updated:	4/21/2016
Start Date:	May 2015
End Date:	September 2015

A Phase 1, Open-label, 3-period, Randomized, Partially Fixed Sequence, 2-way Crossover Study With A Microdose Of [11c]Pf-06427878 Administered With And Without Two Non-radioactive Doses Of Pf-06427878 To Characterize Tissue Distribution Using Positron Emission Tomography In Healthy Adult Male Subjects

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.

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

We found this trial at

sites

Anylan Center

300 Cedar Street
New Haven, Connecticut 06519

from

New Haven, CT