Renal ImpairmentPhase 1NCT01419041
A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
A Phase 1 study testing crizotinib in people with Renal Impairment, run by Pfizer at 3 sites in United States.
Trial summary
The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects
- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 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, and clinical laboratory tests).
- Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (>110 lbs).
- Subjects with Normal Renal Function (Group 1)
- Normal renal function (CLcr =>90 mL/min) during the screening period.
- Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10 kg), gender, and race according to protocol.
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- Subjects with Severe Renal Impairment (Groups 2)
- Good general health commensurate with the population with chronic kidney disease.
- Severe renal impairment (CLcr<30 mL/min) during the screening period.
Who cannot join
- All Subjects
- Renal allograft recipients.
- Any condition possibly affecting drug absorption.
- 12 lead ECG demonstrating QTc >470 msec at screening.
- Urinary incontinence without catheterization.
- A positive urine drug screen.
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- History of regular alcohol consumption.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
- Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- Subjects with Severe Renal Impairment (Groups 2)
- Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable ischemic heart disease), or subjects who are clinically nephrotic.
- Subjects requiring hemodialysis.
- Subjects with strict fluid restriction (ie, <1500 mL/24 hours).
- Significant bleeding diathesis which could preclude multiple venipuncture.
- Use of food or drugs that are CYP3A4 inhibitors and inducers.
- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of trial medication
- Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
The present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
- Conditions
- Renal Impairment
- Being tested
- crizotinib
- Keywords
- renal impairment, crizotinib, pharmacokinetics
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizotinibDrug
Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min)
crizotinibDrug
Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | CLCR: Creatinine clearance Receives: Drug: crizotinib |
| Arm B | Other | CLCR: Creatinine clearance Receives: Drug: crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib
Measured: 18 months
Plasma Cmax (Maximum plasma concentration) for crizotinib
Measured: 18 months
Secondary outcomes (22)
Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib
Measured: 18 months
Tmax (Time to Cmax) for crizotinib
Measured: 18 months
t1/2 (terminal half-life) for crizotinib
Measured: 18 months
CL/F (Apparent oral clearance) for crizotinib
Measured: 18 months
Vz/F (Apparent volume of distribution after oral dose) for crizotinib
Measured: 18 months
fu (fraction of unbound drug in plasma) for crizotinib
Measured: 18 months
AUCinf,u (unbound AUCinf) for crizotinib
Measured: 18 months
AUClast,u (unbound AUClast) for crizotinib
Measured: 18 months
Cmax,u (unbound Cmax) for crizotinib
Measured: 18 months
CL/Fu (unbound apparent oral clearance) for crizotinib
Measured: 18 months
CLR (Renal clearance) for crizotinib
Measured: 18 months
Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib
Measured: 18 months
Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib
Measured: 18 months
AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182
Measured: 18 months
AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182
Measured: 18 months
Cmax (Maximum plasma concentration) for PF-06260182
Measured: 18 months
Tmax (Time to Cmax) for PF-06260182
Measured: 18 months
t1/2 (terminal half-life) for PF-06260182
Measured: 18 months
fu (fraction of unbound drug in plasma) for PF-06260182
Measured: 18 months
AUCinf,u (unbound AUCinf) for PF-06260182
Measured: 18 months
AUClast,u (unbound AUClast) for PF-06260182
Measured: 18 months
Cmax,u (unbound Cmax) for PF-06260182
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01419041
- Sponsor's protocol ID
- A8081020
- Status last verified
- Sep 2012
- First submitted
- 16 Aug 2011
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Dose, Parallel-Group Study To Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01419041
- Acronym / sponsor ID
- A8081020
- Conditions
- Renal Impairment
- Keywords
- renal impairment, crizotinib, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Aug 2011 (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 present study is being conducted to evaluate whether or not severe renal impairment has an effect on crizotinib Pharmacokinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Drug: crizotinibCLCR: Creatinine clearance |
| Arm B | Other | Drug: crizotinibCLCR: Creatinine clearance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All Subjects
- Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 65 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, and clinical laboratory tests).
- Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (>110 lbs).
- Subjects with Normal Renal Function (Group 1)
- Normal renal function (CLcr =>90 mL/min) during the screening period.
Key exclusion criteria (18 listed)
- All Subjects
- Renal allograft recipients.
- Any condition possibly affecting drug absorption.
- 12 lead ECG demonstrating QTc >470 msec at screening.
- Urinary incontinence without catheterization.
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 |
|---|---|---|
| crizotinibSingle-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min) | Drug | Arm A |
| crizotinibSingle-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min) | Drug | Arm B |
Primary outcome
Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib
Time frame: 18 months
Plasma Cmax (Maximum plasma concentration) for crizotinib
Time frame: 18 months
22 secondary outcomes
Plasma AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for crizotinib
Time frame: 18 months
Tmax (Time to Cmax) for crizotinib
Time frame: 18 months
t1/2 (terminal half-life) for crizotinib
Time frame: 18 months
CL/F (Apparent oral clearance) for crizotinib
Time frame: 18 months
Vz/F (Apparent volume of distribution after oral dose) for crizotinib
Time frame: 18 months
fu (fraction of unbound drug in plasma) for crizotinib
Time frame: 18 months
AUCinf,u (unbound AUCinf) for crizotinib
Time frame: 18 months
AUClast,u (unbound AUClast) for crizotinib
Time frame: 18 months
Cmax,u (unbound Cmax) for crizotinib
Time frame: 18 months
CL/Fu (unbound apparent oral clearance) for crizotinib
Time frame: 18 months
CLR (Renal clearance) for crizotinib
Time frame: 18 months
Ae (Cumulative amount of drug recovered unchanged in the urine) for crizotinib
Time frame: 18 months
Ae% (Cumulative amount of drug recovered unchanged in the urine expressed as fraction of administered dose) for crizotinib
Time frame: 18 months
AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for PF-06260182
Time frame: 18 months
AUClast (Area under the plasma concentration versus time curve from zero to the last quantifiable concentration) for PF-06260182
Time frame: 18 months
Cmax (Maximum plasma concentration) for PF-06260182
Time frame: 18 months
Tmax (Time to Cmax) for PF-06260182
Time frame: 18 months
t1/2 (terminal half-life) for PF-06260182
Time frame: 18 months
fu (fraction of unbound drug in plasma) for PF-06260182
Time frame: 18 months
AUCinf,u (unbound AUCinf) for PF-06260182
Time frame: 18 months
AUClast,u (unbound AUClast) for PF-06260182
Time frame: 18 months
Cmax,u (unbound Cmax) for PF-06260182
Time frame: 18 months
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 1 Oct 2012.
- 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
3 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 crizotinib in people with Renal Impairment, run by Pfizer at 3 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 9 inclusion and 18 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 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Plasma AUCinf (Area under the plasma concentration versus time curve from zero to infinity) for crizotinib (time frame: 18 months). 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?
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 1 Oct 2012.