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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02410525

Run by

Pfizer

People needed

8

Starts

2015-05-01

Expected to finish

2015-09-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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