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

November 6, 2014 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm
      • Huddinge, Stockholm, Sweden, SE- 141 86
        • Karolinska Trial Alliance (KTA) M62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male volunteers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - 20 mg
Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.
Drug: 20 mg PF-02545920
Subject will receive a single dose of 20 mg PF-02545920.
Experimental: Cohort 2 ( adaptive dose, optional)
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.
Drug: 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.

Drug: PF-02545920
The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
Experimental: Cohort 3 ( adaptive dose, optional)

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
Drug: 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.

Drug: PF-02545920
The dose will be selected based on the results obtained for Cohort 1 and cohort 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central PDE10A enzyme occupancy values in the striatum.
Time Frame: Day 10
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately).
Time Frame: Day 10
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
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 10
Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.
Day 10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 10
Tmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.
Day 10
Average serum concentration
Time Frame: Day 10
Average serum 02545920 during the post-dose positron emission tomography (PET) scan.
Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A8241017
  • 2013-002733-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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