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Completed

NCT Number: NCT01159626

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

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.

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Key information

Conditions

Healthy Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

PF-03463275

Drug

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

Placebo

Drug

Oral single dose as matching placebo

Primary outcomes

  1. Adverse events monitoring

    Time frame: Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 9, 2010
Registry last updated
Apr 20, 2011

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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