Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Palbociclib plus pioglitazone; Drug: Palbociclib plus Modafinil; Drug: Palbociclib alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02222441

A5481039

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Fixed sequence modafinil DDI arm (Cohort 1)

Experimental group

Description:

Fixed sequence study with treatment A of palbociclib alone, followed by treatment B of palbociclib with modafinil in Cohort 1.

Treatment:

Drug: Palbociclib alone

Drug: Palbociclib plus Modafinil

Drug: Palbociclib alone

Fixed sequence pioglitazone DDI arm (Cohort 2)

Experimental group

Description:

For Cohort 2, fixed sequence study with treatment A of palbociclib alone, followed by treatment C of palbociclib with pioglitazone.

Treatment:

Drug: Palbociclib alone

Drug: Palbociclib plus pioglitazone

Drug: Palbociclib alone