Clinical trial NCT02059330: A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
Official title: A Phase 1, Open Label Study To Investigate The Effect Of Dose And Ethnicity On Palbociclib (PD-0332991) Pharmacokinetics In Japanese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Japanese PK-Bridging Study
dose-proportionality study
Palbociclib
PD-0332991
healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, this study will investigate the effect of Japanese ethnicity of palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects must be a healthy male or female of non-childbearing potential
* Subjects must have a BMI (Body Mass Index) between 17.5 and 30.5 kg/m2
* To be eligible for the Japanese cohort, subjects must have 4 biological grandparents who are Japanese that were born in Japan

Exclusion Criteria:

* Any condition affecting drug absorption (eg gastrectomy, achlorhydria, etc)
* Use of prescription or non-prescription drugs
* A QTc-interval \>450msec or a QRS interval \>120msec
* Pregnant or breastfeeding females, females of childbearing potential, and males who are unwilling or unable to use an effective method of contraception for the duration of the study and for 90 days after the last dose of palbociclib in the study

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0-120 hours
measure: Dose-normalised Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0-120 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-120 hours
measure: Dose-Normalised Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-120 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0-120 hours
measure: Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0-120 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0-120 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0-120 hours
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0-120 hours
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0-120 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: