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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [11C]PF-06427878; Drug: PF-06427878 10 mg; Drug: PF-06427878 600 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410525

B7871003

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 3 patient groups

[11C]PF-06427878

Experimental group

Description:

Single intravenous infusion of \[11C\]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability

Treatment:

Drug: [11C]PF-06427878

PF-06427878 10 mg

Experimental group

Description:

Single oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability

Treatment:

Drug: PF-06427878 10 mg

PF-06427878 600 mg

Experimental group

Description:

Single oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability

Treatment:

Drug: PF-06427878 600 mg