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

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-03463275
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159626
A9131010

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups

Single dose
Experimental group
Treatment:
Drug: PF-03463275
Drug: Placebo
Drug: Placebo
Drug: PF-03463275
Drug: PF-03463275
Drug: PF-03463275
Multiple dose
Experimental group
Treatment:
Drug: PF-03463275
Drug: Placebo
Drug: Placebo
Drug: PF-03463275
Drug: PF-03463275
Drug: PF-03463275

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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