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