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Completed

NCT Number: NCT02222441

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palbociclib Alone

Drug

A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.

Other names: Palbociclib, PD-0332991

Palbociclib plus Modafinil

Drug

For Cohort 1, modafinil 200 mg once daily for 7 days, followed by 400 mg once daily for 25 days; on Day 28, a single oral 125 mg dose of palbociclib will be given with modafinil after a meal, followed by 120 hours of PK sample collection.

Other names: Palbociclib (PD-0332991); Modafinil (Provigil)

Palbociclib plus pioglitazone

Drug

For Cohort 2, pioglitazone 45 mg once daily for a total of 19 days; On Day 15, a single oral 125 mg dose of palbociclib will be given with pioglitazone after a meal, followed by 120 hours of PK sample collection.

Other names: Palbociclib (PD-0332991); Pioglitazone (Actos)

Primary outcomes

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

    Time frame: 0-120 hours

    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).

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0-120 hours

Secondary outcomes

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

    Time frame: 0 to 120 hours

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

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

    Time frame: 0 to 120 hours

  3. Plasma Palbociclib Decay Half-Life (t1/2)

    Time frame: 0 to 120 hours

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  4. Apparent Oral Clearance (CL/F) of Palbociclib

    Time frame: 0 to 120 hours

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  5. Apparent Volume of Distribution (Vz/F) of Palbociclib

    Time frame: 0 to 120 hours

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

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

    Time frame: 0 to 120 hours

  7. Time of last quantifiable concentration for palbociclib

    Time frame: 0 to 120 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2014
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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