CompletedNCT02097433Updated Oct 3, 2014

Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

A Phase 1 interventional study of Dacomitinib in Healthy, sponsored by Pfizer. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-03.

Sponsored by Pfizer · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Allocation: Not applicable
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Read the detailed description

To evaluate the pharmacokinetics of Dacomitinib in Chinese healthy volunteers.

Conditions studied

Healthy

Keywords

Dacomitinib
PF299804
pharmacokinetics
healthy
Chinese

In context

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 1
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

Experimental
Dacomitinib
Drug: Dacomitinib

Interventions

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

What researchers measure

Primary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

Secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05199265
Time frame: 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
Time frame: 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
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 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
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: 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
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose

Study locations

1 site

Peking Union Medical College Hospital
Beijing, 100032, China

References and documents

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 17, 2014
First posted: Mar 27, 2014
Start: Jul 2014
Primary completionActual: Sep 2014
CompletionActual: Sep 2014
Last update: Oct 3, 2014

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02097433
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Mar 27, 2014
Start date: Jul 2014
Primary completion: Sep 2014
Completion: Sep 2014
Last update: Oct 3, 2014

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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