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NCT02124213 Clinical Trial

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

Healthy Clinical Trial

— PET  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02124213
Other study ID # B7441005
Secondary ID 2013-004356-37
Status Completed
Phase Phase 1
First received April 24, 2014
Last updated December 16, 2014
Start date September 2014
Est. completion date October 2014

Study information
Verified date December 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• 30 mg PF-06412562
Subject will receive a single dose of 30 mg PF-06412562
• PF-06412562
The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
• PF-06412562
The dose will be selected based on the results obtained for Cohort 1 and Cohort 2. This Cohort is optional.

Locations
Country Name City State
Sweden Karolinska Trial Alliance (KTA) M62 Huddinge Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary PF-06142562 plasma exposure and RO in the striatum 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 No
Secondary Maximum Observed Plasma Concentration (Cmax) Day 1 No
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) Day 1 No
Secondary Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4) Day 1 No
Secondary Average plasma concentration over 4 hours (Cav,0-4) Day 1 No
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