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Completed

NCT Number: NCT01918202

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

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

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Trial Alliance (KTA) M62

Huddinge, Stockholm County, SE- 141 86, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male volunteers

Exclusion criteria

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

Treatment and study plan

20 mg PF-02545920

Drug

Subject will receive a single dose of 20 mg PF-02545920.

PF-02545920

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 10

    Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.

  3. 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.

  4. Average serum concentration

    Time frame: Day 10

    Average serum 02545920 during the post-dose positron emission tomography (PET) scan.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: PET

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 7, 2013
Registry last updated
Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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