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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01918202
Acronym
PET
Enrollment
9
Registered
2013-08-07
Start date
2014-03-31
Completion date
2014-09-30
Last updated
2014-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Enzyme occupancy, PET, Phosphodiesterase 10 inhibitor

Brief 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.

Interventions

DRUG20 mg PF-02545920

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

DRUGPF-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.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy male volunteers

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Central PDE10A enzyme occupancy values in the striatum.Day 10Using 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

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026