HealthyPhase 1NCT02097433
Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers
A Phase 1 study testing Dacomitinib in people with Healthy, run by Pfizer at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dacomitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Healthy
- Being tested
- Dacomitinib
- Keywords
- Dacomitinib, PF299804, pharmacokinetics, healthy, Chinese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacomitinibDrug
A single 45 mg oral dose of Dacomitinib will be administered under fasted conditions to healthy Chinese volunteers
| Study group | Role | What they receive |
|---|---|---|
| Dacomitinib | Experimental | Not described Receives: Drug: Dacomitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097433
- Sponsor's protocol ID
- A7471051
- Status last verified
- Oct 2014
- First submitted
- 17 Mar 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02097433
- Acronym / sponsor ID
- A7471051
- Conditions
- Healthy
- Keywords
- Dacomitinib, PF299804, pharmacokinetics, healthy, Chinese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dacomitinib | Experimental | Drug: Dacomitinib |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DacomitinibA single 45 mg oral dose of Dacomitinib will be administered under fasted conditions to healthy Chinese volunteers | Drug | Dacomitinib |
Primary outcome
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
Time frame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
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
Time frame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
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.
Plasma Decay Half-Life (t1/2)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
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)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
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.
5 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
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
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
Time frame: predose, 1, 2 ,4, 6, 8, 12, 24, 48 ,72 ,96, 120, 144, 168, 192, 216, 240 ,264 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dacomitinib in people with Healthy, run by Pfizer at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.