Back to resultsStudy Of Palbociclib (PD-0332991) In Renal Impairment
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
palbociclib
palbociclib
palbociclib
palbociclib
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment focused on measuring renal impairment, AUC, Cmax, palbociclib, normal matched subjects
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Any condition possibly affecting drug absorption.
- Renal allograft recipients.
Sites / Locations
- Avail Clinical Research, LLC
- Orlando Clinical Research Center
- Prism Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Normal Renal Function
Mild Renal Impairment
Moderate Renal Impairment
Severe Renal Impairment
Arm Description
Outcomes
Primary Outcome Measures
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).
Maximum Observed Plasma Concentration (Cmax)
Secondary Outcome Measures
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)
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.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
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.
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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.
"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.
Unbound Maximum Observed Plasma Concentration (Cmaxu)
Cmaxu is the highest measured unbound plasma concentration during the dosing interval.
"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.
fraction of unbound drug in plasma (fu)
fraction of drug in plasma or tissues that is not bound to plasma or tissue proteins.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02085538
Brief Title
Study Of Palbociclib (PD-0332991) In Renal Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
renal impairment, AUC, Cmax, palbociclib, normal matched subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
palbociclib
Intervention Description
palbociclib 125 mg oral capsule with food once
Intervention Type
Drug
Intervention Name(s)
palbociclib
Intervention Description
palbociclib 125 mg oral capsule with food once
Intervention Type
Drug
Intervention Name(s)
palbociclib
Intervention Description
palbociclib 125 mg oral capsule with food once
Intervention Type
Drug
Intervention Name(s)
palbociclib
Intervention Description
palbociclib 125 mg oral capsule with food once
Primary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Description
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).
Time Frame
8 days
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
8 days
Title
Apparent Oral Clearance (CL/F)
Description
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
8 days
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
8 days
Title
Apparent Volume of Distribution (Vz/F)
Description
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
8 days
Title
Plasma Decay Half-Life (t1/2)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
8 days
Title
Unbound Apparent Oral Clearance (CLu/F)
Description
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.
Time Frame
8 days
Title
"Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]"
Description
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.
Time Frame
8 days
Title
Unbound Maximum Observed Plasma Concentration (Cmaxu)
Description
Cmaxu is the highest measured unbound plasma concentration during the dosing interval.
Time Frame
8 days
Title
"Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.
Time Frame
8 days
Title
fraction of unbound drug in plasma (fu)
Description
fraction of drug in plasma or tissues that is not bound to plasma or tissue proteins.
Time Frame
8 days
Title
Unbound Apparent Volume of Distribution (Vzu/F)
Description
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.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Any condition possibly affecting drug absorption.
Renal allograft recipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Prism Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5481014&StudyName=Study%20Of%20Palbociclib%20%28PD-0332991%29%20In%20Renal%20Impairment
Description
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Study Of Palbociclib (PD-0332991) In Renal Impairment
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