Renal ImpairmentPhase 1NCT02085538
Study Of Palbociclib (PD-0332991) In Renal Impairment
A Phase 1 study testing palbociclib in people with Renal Impairment, run by Pfizer at 3 sites in United States.
Trial summary
Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. 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?
- palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to May 2016
- 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
- Personally signed and dated informed consent document.
- Renal function calculated by the Cockcroft Gault equation: normal function (CLcr >=90 mL/min), mild: CLcr >=60 mL/min and <90 mL/min, moderate: CLcr >=30 mL/min and <60 mL/min, severe: CLcr <30 mL/min but not requiring hemodialysis.
- Subjects with normal renal function matched for age, weight, gender and race to subjects in impaired renal function groups.
Who cannot join
- Any condition possibly affecting drug absorption.
- Renal allograft recipients.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Avail Clinical Research, LLC
DeLand, Florida, 32720
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Research
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function
Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.
- Conditions
- Renal Impairment
- Being tested
- palbociclib
- Keywords
- renal impairment, AUC, Cmax, palbociclib, normal matched subjects
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palbociclibDrug
palbociclib 125 mg oral capsule with food once
palbociclibDrug
palbociclib 125 mg oral capsule with food once
palbociclibDrug
palbociclib 125 mg oral capsule with food once
palbociclibDrug
palbociclib 125 mg oral capsule with food once
| Study group | Role | What they receive |
|---|---|---|
| Normal Renal Function | Experimental | Not described Receives: Drug: palbociclib |
| Mild Renal Impairment | Experimental | Not described Receives: Drug: palbociclib |
| Moderate Renal Impairment | Experimental | Not described Receives: Drug: palbociclib |
| Severe Renal Impairment | Experimental | Not described Receives: Drug: palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Measured: 8 days
Maximum Observed Plasma Concentration (Cmax)
Measured: 8 days
Secondary outcomes (11)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 8 days
Apparent Oral Clearance (CL/F)
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: 8 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 8 days
Apparent Volume of Distribution (Vz/F)
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: 8 days
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 8 days
Unbound Apparent Oral Clearance (CLu/F)
Clearance of unbound 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 oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood.
Measured: 8 days
"Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]"
AUC (0 - ∞)u= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - ∞)u for unbound drug.
Measured: 8 days
Unbound Maximum Observed Plasma Concentration (Cmaxu)
Cmaxu is the highest measured unbound plasma concentration during the dosing interval.
Measured: 8 days
"Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.
Measured: 8 days
fraction of unbound drug in plasma (fu)
fraction of drug in plasma or tissues that is not bound to plasma or tissue proteins.
Measured: 8 days
Unbound Apparent Volume of Distribution (Vzu/F)
Unbound Volume of distribution is defined as the theoretical volume in which the total unbound amount of drug would need to be uniformly distributed to produce the desired unbound plasma concentration of a drug. Unbound Apparent volume of distribution after oral dose (Vzu/F) is influenced by the fraction absorbed.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT02085538
- Sponsor's protocol ID
- A5481014
- Status last verified
- Apr 2018
- First submitted
- 11 Mar 2014
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT02085538
- Acronym / sponsor ID
- A5481014
- Conditions
- Renal Impairment
- Keywords
- renal impairment, AUC, Cmax, palbociclib, normal matched subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 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.
Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Renal Function | Experimental | Drug: palbociclib |
| Mild Renal Impairment | Experimental | Drug: palbociclib |
| Moderate Renal Impairment | Experimental | Drug: palbociclib |
| Severe Renal Impairment | Experimental | Drug: palbociclib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Personally signed and dated informed consent document.
- Renal function calculated by the Cockcroft Gault equation: normal function (CLcr >=90 mL/min), mild: CLcr >=60 mL/min and <90 mL/min, moderate: CLcr >=30 mL/min and <60 mL/min, severe: CLcr <30 mL/min but not requiring hemodialysis.
- Subjects with normal renal function matched for age, weight, gender and race to subjects in impaired renal function groups.
Key exclusion criteria (2 listed)
- Any condition possibly affecting drug absorption.
- Renal allograft recipients.
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 |
|---|---|---|
| palbociclibpalbociclib 125 mg oral capsule with food once | Drug | Normal Renal Function |
| palbociclibpalbociclib 125 mg oral capsule with food once | Drug | Mild Renal Impairment |
| palbociclibpalbociclib 125 mg oral capsule with food once | Drug | Moderate Renal Impairment |
| palbociclibpalbociclib 125 mg oral capsule with food once | Drug | Severe Renal Impairment |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 8 days
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 8 days
11 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 8 days
Apparent Oral Clearance (CL/F)
Time frame: 8 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 8 days
Apparent Volume of Distribution (Vz/F)
Time frame: 8 days
Plasma Decay Half-Life (t1/2)
Time frame: 8 days
Unbound Apparent Oral Clearance (CLu/F)
Time frame: 8 days
"Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]"
Time frame: 8 days
Unbound Maximum Observed Plasma Concentration (Cmaxu)
Time frame: 8 days
"Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"
Time frame: 8 days
fraction of unbound drug in plasma (fu)
Time frame: 8 days
Unbound Apparent Volume of Distribution (Vzu/F)
Time frame: 8 days
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 30 Apr 2018.
- 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 palbociclib 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 3 inclusion and 2 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 30 Apr 2018. 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?
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] (time frame: 8 days). 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 30 Apr 2018.