NCT03686501

D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562

An Open-Label Study To Evaluate D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562, Using Positron Emission Tomography (PET) With Ligand [18F]MNI-968 in Healthy Male Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To assess the D1 receptor occupancy (D1 RO) in striatum after a single oral administration of PF-06412562.

Detailed description

Primary Objectives: * To assess the D1 receptor occupancy (D1 RO) in striatum after a single oral administration of PF-06412562 * To assess the relationship of D1 RO in the striatum versus plasma exposure of PF-06412562 after a single oral administration. Secondary Objective: • To evaluate the plasma exposure of PF-06412562for the duration of PET scan following a single oral administration of PF-06412562. Safety Objectives: • To evaluate the safety and tolerability of PF-06412562 of single oral doses of PF-06412562.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	PF-06412562	Healthy Volunteers recruited for the study will undergo a single dose of PF-06412562 and will undergo two \[18F\]MNI-968 injections

Timeline

• Start date: 2018-09-10
• Primary completion: 2019-03-28
• Completion: 2019-03-28
• First posted: 2018-09-27
• Last updated: 2019-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study