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.
- Registration Number
- NCT01756781
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 PD-0332991 Subjects randomized to Sequence 1 will receive Treatment A followed by Treatment B. Treatment A is a single 2 mg oral dose of midazolam alone. Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose. Sequence 2 PD-0332991 Subjects randomized to Sequence 2 will receive Treatment B followed by Treatment A with a washout of no less than 14 days in between.Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose. There will be a minimum washout of 14 days prior to beginning Treatment A. Treatment A is a single 2 mg oral dose of midazolam alone. Sequence 1 Midazolam Subjects randomized to Sequence 1 will receive Treatment A followed by Treatment B. Treatment A is a single 2 mg oral dose of midazolam alone. Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose. Sequence 2 Midazolam Subjects randomized to Sequence 2 will receive Treatment B followed by Treatment A with a washout of no less than 14 days in between.Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose. There will be a minimum washout of 14 days prior to beginning Treatment A. Treatment A is a single 2 mg oral dose of midazolam alone.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸South Miami, Florida, United States