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.
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01756781
- Run by
- Pfizer
- People needed
- 26
- Starts
- 2013-05-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-10-08
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — South Miami, Florida, United States
Full record on ClinicalTrials.gov
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