HealthyPhase 1NCT01571388
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
A Phase 1 study testing dacomitinib in people with Healthy and Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction, run by Pfizer at 2 sites in United States.
Trial summary
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
- 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
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Aug 2012
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 years of age to <75 years of age. 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 and clinical laboratory tests. Liver function tests, albumin and prothrombin time must be within normal range.
- Body Mass Index (BMI) of 18 to 35 kg/m2;
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects in the normal hepatic function group (Group 1): No known or suspected hepatic impairment.
- For subjects in the hepatic impairment groups (Groups 2 and 3):
Show all 10Show fewer
- Should satisfy the criteria for Class A or B of the modified Child-Pugh classification
- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, CT scan, or MRI.
- Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days, as documented by the subject's recent medical history
- Must be on a stable dose of medication and/or treatment regimen.
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy, chronic diarrhea, rapid transit).
- A positive urine drug screen.
- Females of childbearing potential, including those with tubal ligation. [To be considered for enrollment, women of at least 45 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at screening].
- In addition, subjects in the hepatic impairment groups (Groups 2 and 3) presenting with any of the following will not be included in the trial:
- Hepatic carcinoma and hepatorenal syndrome or life expectancy <1 year.
- Undergone porta-caval shunt surgery.
- History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than one month prior to study entry.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Phase 1 Study To Evaluate The Single Dose Pharmacokinetics Of Dacomitinib (PF-00299804) In Subjects With Impaired Hepatic Function
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
- Being tested
- dacomitinib
- Keywords
- dacomitinib, PF-00299804, hepatic impairment, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dacomitinibDrug
Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
dacomitinibDrug
Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
dacomitinibDrug
Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Healthy Subjects to receive dacomitinib Receives: Drug: dacomitinib |
| Group 2 | Experimental | Subjects with mildly impaired hepatic function to receive dacomitinib Receives: Drug: dacomitinib |
| Group 3 | Experimental | Subjects with moderately impaired hepatic function to receive dacomitinib Receives: Drug: dacomitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximal plasma concentration (Cmax) for dacomitinib
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for dacomitinib
Measured: 2 weeks
Secondary outcomes (31)
Area under the Concentration-Time Curve (AUC);Plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for dacomitinib
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for dacomitinib
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for dacomitinib
Measured: 2 weeks
Time of first observed maximal plasma concentration (Tmax) for dacomitinib
Measured: 2 weeks
Plasma elimination half life (t1/2) of dacomitinib
Measured: 2 weeks
Apparent plasma clearance (CL/F) of dacomitinib
Measured: 2 weeks
Apparent volume of distribution (Vz/F) of dacomitinib
Measured: 2 weeks
Fraction of unbound dacomitinib in plasma (fu)
Measured: 2 weeks
Unbound apparent plasma clearance (CL/F) of dacomitinib ,
Measured: 2 weeks
Unbound apparent volume of distribution (Vz/F) of dacomitinib
Measured: 2 weeks
Unbound Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for dacomitinib
Measured: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for dacomitinib
Measured: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for dacomitinib
Measured: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for dacomitinib
Measured: 2 weeks
Maximal unbound plasma concentration (Cmax) for dacomitinib
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for PF-05199265
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for PF-05199265
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for PF-05199265
Measured: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for PF-05199265
Measured: 2 weeks
Maximal plasma concentration (Cmax) for PF-05199265
Measured: 2 weeks
Time of first observed maximal plasma concentration (Tmax) for PF-05199265
Measured: 2 weeks
Metabolite ratio for plasma area under plasma concentration-time curve from time zero to time infinity post dose (MRAUCinf)
Measured: 2 weeks
Metabolite ratio for plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (MRAUClast)
Measured: 2 weeks
Metabolite ratio for maximal plasma concentration (MRCmax)
Measured: 2 weeks
Fraction of unbound PF-05199265 in plasma (fu)
Measured: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for PF-05199265
Measured: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for PF-05199265
Measured: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for PF-05199265
Measured: 2 weeks
Unbound Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for PF-05199265
Measured: 2 weeks
Maximal unbound plasma concentration (Cmax) for PF-05199265
Measured: 2 weeks
Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01571388
- Sponsor's protocol ID
- A7471018
- Status last verified
- Dec 2013
- First submitted
- 3 Apr 2012
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Piscitelli J, Chen J, LaBadie RR, Salageanu J, Chung CH, Tan W. The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib. Clin Drug Investig. 2022 Mar;42(3):221-235. doi: 10.1007/s40261-022-01125-x. Epub 2022 Feb 23.
PubMed 35195881Giri N, Masters JC, Plotka A, Liang Y, Boutros T, Pardo P, O'Connell J, Bello C. Investigation of the impact of hepatic impairment on the pharmacokinetics of dacomitinib. Invest New Drugs. 2015 Aug;33(4):931-41. doi: 10.1007/s10637-015-0256-0. Epub 2015 Jun 6.
PubMed 26048096
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Evaluate The Single Dose Pharmacokinetics Of Dacomitinib (PF-00299804) In Subjects With Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT01571388
- Acronym / sponsor ID
- A7471018
- Keywords
- dacomitinib, PF-00299804, hepatic impairment, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Apr 2012 (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.
The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: dacomitinibHealthy Subjects to receive dacomitinib |
| Group 2 | Experimental | Drug: dacomitinibSubjects with mildly impaired hepatic function to receive dacomitinib |
| Group 3 | Experimental | Drug: dacomitinibSubjects with moderately impaired hepatic function to receive dacomitinib |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 years of age to <75 years of age. 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 and clinical laboratory tests. Liver function tests, albumin and prothrombin time must be within normal range.
- Body Mass Index (BMI) of 18 to 35 kg/m2;
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Subjects in the normal hepatic function group (Group 1): No known or suspected hepatic impairment.
Key exclusion criteria (7 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy, chronic diarrhea, rapid transit).
- A positive urine drug screen.
- Females of childbearing potential, including those with tubal ligation. [To be considered for enrollment, women of at least 45 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at screening].
- In addition, subjects in the hepatic impairment groups (Groups 2 and 3) presenting with any of the following will not be included in the trial:
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 |
|---|---|---|
| dacomitinibSubjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1. | Drug | Group 1 |
| dacomitinibSubjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1. | Drug | Group 2 |
| dacomitinibSubjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1. | Drug | Group 3 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 2 weeks
Maximal plasma concentration (Cmax) for dacomitinib
Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for dacomitinib
Time frame: 2 weeks
31 secondary outcomes
Area under the Concentration-Time Curve (AUC);Plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for dacomitinib
Time frame: 2 weeks
Plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for dacomitinib
Time frame: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for dacomitinib
Time frame: 2 weeks
Time of first observed maximal plasma concentration (Tmax) for dacomitinib
Time frame: 2 weeks
Plasma elimination half life (t1/2) of dacomitinib
Time frame: 2 weeks
Apparent plasma clearance (CL/F) of dacomitinib
Time frame: 2 weeks
Apparent volume of distribution (Vz/F) of dacomitinib
Time frame: 2 weeks
Fraction of unbound dacomitinib in plasma (fu)
Time frame: 2 weeks
Unbound apparent plasma clearance (CL/F) of dacomitinib ,
Time frame: 2 weeks
Unbound apparent volume of distribution (Vz/F) of dacomitinib
Time frame: 2 weeks
Unbound Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for dacomitinib
Time frame: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for dacomitinib
Time frame: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for dacomitinib
Time frame: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for dacomitinib
Time frame: 2 weeks
Maximal unbound plasma concentration (Cmax) for dacomitinib
Time frame: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for PF-05199265
Time frame: 2 weeks
Plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for PF-05199265
Time frame: 2 weeks
Plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for PF-05199265
Time frame: 2 weeks
Plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for PF-05199265
Time frame: 2 weeks
Maximal plasma concentration (Cmax) for PF-05199265
Time frame: 2 weeks
Time of first observed maximal plasma concentration (Tmax) for PF-05199265
Time frame: 2 weeks
Metabolite ratio for plasma area under plasma concentration-time curve from time zero to time infinity post dose (MRAUCinf)
Time frame: 2 weeks
Metabolite ratio for plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (MRAUClast)
Time frame: 2 weeks
Metabolite ratio for maximal plasma concentration (MRCmax)
Time frame: 2 weeks
Fraction of unbound PF-05199265 in plasma (fu)
Time frame: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 24 hours post dose (AUC24) for PF-05199265
Time frame: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to 216 hours post dose (AUC216) for PF-05199265
Time frame: 2 weeks
Unbound plasma area under plasma concentration-time curve from time zero to time of last quantifiable concentration post dose (AUClast) for PF-05199265
Time frame: 2 weeks
Unbound Plasma area under plasma concentration-time curve from time zero to time infinity post dose (AUCinf) for PF-05199265
Time frame: 2 weeks
Maximal unbound plasma concentration (Cmax) for PF-05199265
Time frame: 2 weeks
Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
Time frame: 6-8 weeks
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 18 Dec 2013.
- Derived from this study: PubMed 35195881Piscitelli J, Chen J, LaBadie RR, Salageanu J, Chung CH, Tan W. The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib. Clin Drug Investig. 2022 Mar;42(3):221-235. doi: 10.1007/s40261-022-01125-x. Epub 2022 Feb 23.
- Derived from this study: PubMed 26048096Giri N, Masters JC, Plotka A, Liang Y, Boutros T, Pardo P, O'Connell J, Bello C. Investigation of the impact of hepatic impairment on the pharmacokinetics of dacomitinib. Invest New Drugs. 2015 Aug;33(4):931-41. doi: 10.1007/s10637-015-0256-0. Epub 2015 Jun 6.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
2 sites 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 and Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction, run by Pfizer at 2 sites in United States.
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 10 inclusion and 7 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571388, which also lists 2 linked publications.
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 18 Dec 2013.