NCT01918202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

August 5, 2013

Last Update Submit

November 6, 2014

Conditions

Healthy

Keywords

Enzyme occupancyPETPhosphodiesterase 10 inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately).

    Day 10

  • Maximum Observed Plasma Concentration (Cmax)

    Day 10

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Day 10

  • Average serum concentration

    Day 10

Study Arms (3)

Cohort 1 - 20 mg

EXPERIMENTAL

Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.

Drug: 20 mg PF-02545920

Cohort 2 ( adaptive dose, optional)

EXPERIMENTAL

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

Cohort 3 ( adaptive dose, optional)

EXPERIMENTAL

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

Interventions

20 mg PF-02545920DRUG

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

Cohort 1 - 20 mg
PF-02545920DRUG

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)

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Trial Alliance (KTA) M62

Huddinge, Stockholm County, SE- 141 86, Sweden

Location

Related Publications (1)

  • Delnomdedieu M, Forsberg A, Ogden A, Fazio P, Yu CR, Stenkrona P, Duvvuri S, David W, Al-Tawil N, Vitolo OV, Amini N, Nag S, Halldin C, Varrone A. In vivo measurement of PDE10A enzyme occupancy by positron emission tomography (PET) following single oral dose administration of PF-02545920 in healthy male subjects. Neuropharmacology. 2017 May 1;117:171-181. doi: 10.1016/j.neuropharm.2017.01.016. Epub 2017 Jan 22.

    PMID: 28122201DERIVED

Related Links

MeSH Terms

Interventions

2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 7, 2013

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

SE(1)