Clinical trial NCT02085538: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: renal impairment
AUC
Cmax
palbociclib
normal matched subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 8 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 8 days
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 8 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 8 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 8 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 8 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 8 days
measure: Unbound Apparent Oral Clearance (CLu/F)
timeFrame: 8 days
measure: "Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]"
timeFrame: 8 days
measure: Unbound Maximum Observed Plasma Concentration (Cmaxu)
timeFrame: 8 days
measure: "Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)"
timeFrame: 8 days
measure: fraction of unbound drug in plasma (fu)
timeFrame: 8 days
measure: Unbound Apparent Volume of Distribution (Vzu/F)
timeFrame: 8 days
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Saint Paul
country: United States
facility: Prism Research
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: