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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01159626

Enrollment

Registered

2010-07-09

Start date

2010-07-31

Completion date

2010-11-30

Last updated

2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase1, Pharmacokinetics, Healthy Male, Japanese, Schizophrenia

Brief summary

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.

Interventions

DRUGPF-03463275

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

DRUGPlacebo

Oral single dose as matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026