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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.

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Midazolam (Drug); PD-0332991 (Drug); Midazolam (Drug); PD-0332991 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Midazolam Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

Secondary outcome:

Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Maximum Observed Plasma Midazolam Concentration (Cmax)

Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)

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

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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.


Inclusion Criteria:

- Healthy females of non-child bearing potential between the ages of 18 and 65 years


- A Body Mass Index (BMI) of 17. 5 to 32. 0 kg/m2 and a total body weight >50 kg (110


- 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.

Locations and Contacts

Pfizer Investigational Site, South Miami, Florida 33143, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2013
Last updated: December 16, 2013

Page last updated: August 23, 2015

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