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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 30 mg PF-06412562; Drug: PF-06412562

Study type: Interventional

Funder types: Industry

Identifiers

NCT02124213

2013-004356-37 (EudraCT Number)

B7441005

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Cohor 1 - 30 mg

Experimental group

Description:

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

Treatment:

Drug: 30 mg PF-06412562

Cohort 2 ( adaptive dose, optional)

Experimental group

Description:

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.

Treatment:

Drug: PF-06412562

Drug: PF-06412562

Cohort 3 ( adaptive dose, optional)

Experimental group

Description:

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.

Treatment:

Drug: PF-06412562

Drug: PF-06412562