Clinical trial NCT02222441: Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)
Official title: A Phase 1, Open-label, Fixed-sequence, 2-cohort, 2-period Study To Investigate The Effect Of Modafinil And Pioglitazone Given As Multiple Doses On Single Dose Pharmacokinetics Of Palbociclib (Pd-0332991) In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Palbociclib
Modafinil
Pioglitazone
Pharmacokinetics
Drug-Drug Interaction Study
Healthy Volunteers
CYP3A Inducers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the potential effect of the moderate CYP3A inducer modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subjects with a self-reported history of addiction, especially to stimulants.
* A positive urine drug screen or alcohol breath test.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0-120 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-120 hours
Secondary outcomes:
measure: Plasma Palbociclib Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 120 hours
measure: Plasma Palbociclib Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 to 120 hours
measure: Plasma Palbociclib Decay Half-Life (t1/2)
timeFrame: 0 to 120 hours
measure: Apparent Oral Clearance (CL/F) of Palbociclib
timeFrame: 0 to 120 hours
measure: Apparent Volume of Distribution (Vz/F) of Palbociclib
timeFrame: 0 to 120 hours
measure: Trough Plasma Concentrations of Modafinil, Modafinil sulfone, pioglitazone, hydroxy derivative of pioglitazone, and keto derivative of pioglitazone
timeFrame: 0 to 120 hours
measure: Time of last quantifiable concentration for palbociclib
timeFrame: 0 to 120 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: