Clinical trial NCT02097433: Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Dacomitinib
PF299804
pharmacokinetics
healthy
Chinese
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: To evaluate the pharmacokinetics of Dacomitinib in Chinese healthy volunteers.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Apparent Volume of Distribution (Vz/F)of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Plasma Decay Half-Life (t1/2)of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Apparent Oral Clearance (CL/F)of Dacomitinib
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05199265
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of PF-05199265
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of PF-05199265
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of PF-05199265
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
measure: Plasma Decay Half-Life (t1/2)of PF-05199265
timeFrame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: