A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers (PET)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 20 mg PF-02545920; Drug: PF-02545920

Study type: Interventional

Funder types: Industry

Identifiers

NCT01918202

A8241017

2013-002733-38 (EudraCT Number)

Details and patient eligibility

About

This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.

Enrollment: 9 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male volunteers

Exclusion criteria

• History of orthostatic hypotension
• History of prior radiation exposure for research purposes, or radiation therapy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Cohort 1 - 20 mg

Experimental group

Description:

Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.

Treatment:

Drug: 20 mg PF-02545920

Cohort 2 ( adaptive dose, optional)

Experimental group

Description:

Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.

Treatment:

Drug: PF-02545920

Drug: PF-02545920

Cohort 3 ( adaptive dose, optional)

Experimental group

Description:

Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional

Treatment:

Drug: PF-02545920

Drug: PF-02545920