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

NCT ID: NCT02124213

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Receptor Occupancy PET D1 Receptor Agonist

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohor 1 - 30 mg

Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562.

Group Type EXPERIMENTAL

30 mg PF-06412562

Intervention Type DRUG

Subject will receive a single dose of 30 mg PF-06412562

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.

Group Type EXPERIMENTAL

PF-06412562

Intervention Type DRUG

The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.

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.

Group Type EXPERIMENTAL

PF-06412562

Intervention Type DRUG

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

This Cohort is optional.

Interventions

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30 mg PF-06412562

Subject will receive a single dose of 30 mg PF-06412562

Intervention Type DRUG

PF-06412562

The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.

Intervention Type DRUG

PF-06412562

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

This Cohort is optional.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Karolinska Trial Alliance (KTA) M62

Huddinge, Stockholm County, Sweden

Site Status

Countries

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Sweden

Related Links

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Other Identifiers

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2013-004356-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7441005

Identifier Type: -

Identifier Source: org_study_id