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.
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | July 2013 |
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
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.
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.
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.
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