A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.

Pfizer26 enrolled

Overview

This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2. Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in treatment period 1, and following a washout period of no less than 14 days they will receive midazolam alone in treatment period 2.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy females of non-child bearing potential between the ages of 18 and 65 years old. * A Body Mass Index (BMI) of 17.5 to 32.0 kg/m2 and a total body weight \>50 kg (110 lbs). * A signed informed consent document. Exclusion Criteria: * Any evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * A positive urine drug screen. * Pregnant or nursing females. * Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of study medication.

Outcomes

Primary Outcomes

Midazolam 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).

Time frame: 0-36hrs post midazolam dose

Secondary Outcomes

Midazolam 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)

Time frame: 0-36 hrs post midazolam dose

Maximum Observed Plasma Midazolam Concentration (Cmax)

Time frame: 0-36 hrs post midazolam dose

Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)

Time frame: 0-36 hrs post midazolam dose

Plasma Decay Half-Life (t1/2) of Midazolam

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 0-36 hrs post midazolam dose

Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991

Time frame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose

A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes