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Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Peking Union Medical College Hospital
Beijing, , 100032 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02097433
Pfizer
Completed
Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

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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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Healthy
Drug: Dacomitinib
A single 45 mg oral dose of Dacomitinib will be administered under fasted conditions to healthy Chinese volunteers
Experimental: Dacomitinib
Intervention: Drug: Dacomitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
September 2014
September 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02097433
A7471051
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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