Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects

Study Overview
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Brief Summary
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This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-03463275 oral controlled release formulation in Japanese and Western male subjects.

Official Title
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A Phase 1, Randomized, Subject- and Investigator-blind, Sponsor-open, Placebo-controlled, Single- and Multiple-dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of PF-03463275 in Healthy Male Japanese and Western Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-03463275
* Drug: PF-03463275
* Drug: PF-03463275
* Drug: Placebo
* Drug: PF-03463275
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs). Japanese subjects must have four Japanese grandparents who were born in Japan. Exclusion Criteria: Subjects that are genotyped to be PM (poor metabolizer), UM (ultrarapid metabolizer), IM/EM and EM/UM for CYP2D6 status. Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose<br> | Drug: PF-03463275<br>* Oral single 20 mg dose as two 10mg controlled release tablets<br>Drug: PF-03463275<br>* Oral single 40 mg dose as four 10mg controlled release tablets<br>Drug: PF-03463275<br>* Oral single 60 mg dose as six 10mg controlled release tablets<br>Drug: Placebo<br>* Oral single dose as matching placebo<br>|
| Experimental: Multiple dose<br> | Drug: PF-03463275<br>* Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days<br>Drug: Placebo<br>* Oral multiple doses as matching placebo for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events monitoring |  | Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B | 
| Vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, suicidality assessment |  | Screening and Day 0 to Day 4 in each period of Cohort A, Screening and Day 0 to Day 10 in Cohort B | 
| Serum (after single dose): Cmax, AUClast, AUCtau (Calculated only in Cohort B) and as data permit Tmax, AUCinf, t1/2 |  | Day 1 to Day 4 in each period of Cohort A, Day 1 in Cohort B | 
| Serum (after multiple dose): Ctrough, Cmax*, AUCtau* and as data permit Tmax*, t1/2* and Rac* (accumulation ratio) * Calculated only after the last administration. |  | Day 2 to Day 10 in Cohort B | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase1, Pharmacokinetics, Healthy Male, Japanese, Schizophrenia