Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

NCT02097433 | Completed Phase 1

• 1 other identifier: A7471051
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Dacomitinib; PF299804; pharmacokinetics; healthy; Chinese

Outcome Measures

Primary Outcomes (7)

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of Dacomitinib

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Dacomitinib

  AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Dacomitinib

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Apparent Volume of Distribution (Vz/F)of Dacomitinib

  Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Plasma Decay Half-Life (t1/2)of Dacomitinib

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Apparent Oral Clearance (CL/F)of Dacomitinib

  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

Secondary Outcomes (5)

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05199265

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of PF-05199265

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of PF-05199265

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of PF-05199265

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

• Plasma Decay Half-Life (t1/2)of PF-05199265

  predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

Study Arms (1)

Dacomitinib

EXPERIMENTAL

Drug: Dacomitinib

Interventions

Dacomitinib DRUG

A single 45 mg oral dose of Dacomitinib will be administered under fasted conditions to healthy Chinese volunteers

Dacomitinib

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

dacomitinib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 27, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

CN (1)