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

Pfizer40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-03463275DRUG

Oral single 20 mg dose as two 10mg controlled release tablets

PF-03463275DRUG

Oral single 40 mg dose as four 10mg controlled release tablets

PF-03463275DRUG

Oral single 60 mg dose as six 10mg controlled release tablets

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Pfizer Investigational Site

Glendale, California, United States

Outcomes

Primary Outcomes

Adverse events monitoring

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Day 2 to Day 10 in Cohort B

Data from ClinicalTrials.gov

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