Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

A Phase 1 Open-label Study To Characterize The Pharmacokinetics Of A Single 45 Mg Oral Dose Of Dacomitinib (Pf-00299804) In Healthy Chinese Subjects

As part of the global clinical development program for Dacomitinib, studies are planned in cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.

The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.

To evaluate the pharmacokinetics of Dacomitinib in Chinese healthy volunteers.

Inclusion Criteria:

• Healthy Chinese volunteers (individuals currently residing in mainland China, who were born in China, and whose parents are both of Chinese descent).
• Healthy male and/or female (of non-childbearing potential) subjects between the ages of 18 and 45 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests).
• Body Mass Index (BMI) of 19.0 to 24.0 kg/m2; and a total body weight should be 50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant dermatologic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• Drug dependency, a positive urine drug screen and/or alcohol dependency.
• Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• Treatment with an investigational drug or biologic within the last 3 months (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication, whichever is longer.