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NCT01918202 Clinical Trial

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

Healthy Clinical Trial

— PET  

Official title:
A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01918202
Other study ID # A8241017
Secondary ID 2013-002733-38
Status Completed
Phase Phase 1
First received August 5, 2013
Last updated November 6, 2014
Start date March 2014
Est. completion date September 2014

Study information
Verified date November 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria:

- healthy male volunteers

Exclusion Criteria:

- History of orthostatic hypotension

- History of prior radiation exposure for research purposes, or radiation therapy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• 20 mg PF-02545920
Subject will receive a single dose of 20 mg PF-02545920.
• 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.
• PF-02545920
The dose will be selected based on the results obtained for Cohort 1 and cohort 2.

Locations
Country Name City State
Sweden Karolinska Trial Alliance (KTA) M62 Huddinge Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central PDE10A enzyme occupancy values in the striatum. Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, the central PDE10A enzyme occupancy values will be measured in the striatum at different single oral doses of PF-02545920. Day 10 No
Secondary Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately). Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen be measured (separately) at different single oral doses of PF-02545920. Day 10 No
Secondary Maximum Observed Plasma Concentration (Cmax) Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan. Day 10 No
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) Tmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan. Day 10 No
Secondary Average serum concentration Average serum 02545920 during the post-dose positron emission tomography (PET) scan. Day 10 No
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