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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 20 mg PF-02545920; Drug: PF-02545920

• Registration Number: NCT01918202
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Study Start: 2014-03
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

• healthy male volunteers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1 - 20 mg	20 mg PF-02545920	Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.
Cohort 3 ( adaptive dose, optional)	PF-02545920	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
Cohort 2 ( adaptive dose, optional)	PF-02545920	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.

Primary Outcome Measures

Name	Time	Method
Central PDE10A enzyme occupancy values in the striatum.	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 Outcome Measures

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

Trial Locations

Locations (1)

Karolinska Trial Alliance (KTA) M62; 🇸🇪 Huddinge, Stockholm, Sweden