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.

A Phase 1 Randomized, Open-Label, 2-Sequence, 2-Period Crossover Study Of The Effect Of Multiple Doses Of PD-0332991 On Midazolam Pharmacokinetics In Healthy Women of Non-Childbearing Potential

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01756781

Enrollment

Registered

2012-12-27

Start date

2013-05-31

Completion date

2013-07-31

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PD-0332991, Midazolam, Drug-Drug Interaction Study, Healthy Adult Volunteer

Brief summary

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.

Interventions

DRUGMidazolam

Treatment A includes a single 2 mg oral dose of midazolam alone. Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.

DRUGPD-0332991

Treatment B includes 8 daily 125 mg oral doses of PD-0332991.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Midazolam Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	0-36hrs post midazolam dose	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).

Secondary

Measure	Time frame	Description
Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0-36 hrs post midazolam dose	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Maximum Observed Plasma Midazolam Concentration (Cmax)	0-36 hrs post midazolam dose	—
Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)	0-36 hrs post midazolam dose	—
Plasma Decay Half-Life (t1/2) of Midazolam	0-36 hrs post midazolam dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991	Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026