A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers (PET)

December 16, 2014 updated by: Pfizer

Open Label Adaptive Design Study To Evaluate D1 Receptor Occupancy (ro) Following Single Dose Of Pf-06412562, Using Positron Emission Tomography (Pet) With Ligand [11c]sch23390 In Healthy Male Subjects

This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Healthy Male Volunteers

Exclusion Criteria:

Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohor 1 - 30 mg
Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562.
Drug: 30 mg PF-06412562
Subject will receive a single dose of 30 mg PF-06412562
Experimental: Cohort 2 ( adaptive dose, optional)
Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1.
Drug: PF-06412562
The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
Drug: PF-06412562

The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.

This Cohort is optional.
Experimental: Cohort 3 ( adaptive dose, optional)
Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.
Drug: PF-06412562
The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
Drug: PF-06412562

The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.

This Cohort is optional.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PF-06142562 plasma exposure and RO in the striatum
Time Frame: Day 1
Using Positron Emission Tomography and a radiotracer [11C]SCH23390, the PF-06142562 plasma exposure and RO in the striatum (average of caudate and putamen) will be measured in healthy male subjects.
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 1
Day 1
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1
Day 1
Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4)
Time Frame: Day 1
Day 1
Average plasma concentration over 4 hours (Cav,0-4)
Time Frame: Day 1
Day 1

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.

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

September 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B7441005
  • 2013-004356-37 (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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