Clinical trial NCT01756781: 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.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PD-0332991
Midazolam
Drug-Drug Interaction Study
Healthy Adult Volunteer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-27
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Midazolam Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0-36hrs post midazolam dose
Secondary outcomes:
measure: Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0-36 hrs post midazolam dose
measure: Maximum Observed Plasma Midazolam Concentration (Cmax)
timeFrame: 0-36 hrs post midazolam dose
measure: Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)
timeFrame: 0-36 hrs post midazolam dose
measure: Plasma Decay Half-Life (t1/2) of Midazolam
timeFrame: 0-36 hrs post midazolam dose
measure: Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991
timeFrame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: