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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01159626

Run by

Pfizer

People needed

40

Starts

2010-07-01

Expected to finish

2010-11-01

Last updated by the study team

2011-04-20

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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