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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Palbociclib alone (Drug); Palbociclib plus Modafinil (Drug); Palbociclib alone (Drug); Palbociclib plus pioglitazone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Plasma Palbociclib Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Plasma Palbociclib Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Palbociclib Decay Half-Life (t1/2)

Apparent Oral Clearance (CL/F) of Palbociclib

Apparent Volume of Distribution (Vz/F) of Palbociclib

Trough Plasma Concentrations of Modafinil, Modafinil sulfone, pioglitazone, hydroxy derivative of pioglitazone, and keto derivative of pioglitazone

Time of last quantifiable concentration for palbociclib

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

New Haven Clinical Research Unit, New Haven, Connecticut 06511, United States
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2014
Last updated: February 18, 2015

Page last updated: August 23, 2015

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