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NCT Number: NCT02124213

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

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Karolinska Trial Alliance (KTA) M62

Huddinge, Stockholm County, SE- 141 86, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

30 mg PF-06412562

Drug

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

PF-06412562

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Day 1

  3. Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4)

    Time frame: Day 1

  4. Average plasma concentration over 4 hours (Cav,0-4)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: PET

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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