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Completed

NCT Number: NCT01953731

A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)

This study will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.

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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

Pfizer Investigational Site

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 males or females of non-childbearing potential
  • body mass index between 17.5-30.5 kg/m2 with a total body weight greater than 50kg

Exclusion criteria

  • Evidence or history of any clinically significant physiologic, psychological, or medical conditions
  • a positive drug screen or alcohol breath test
  • a baseline ECG demonstrating a QTc>450msecs or a QRS interval >120msecs

Treatment and study plan

Palbociclib

Drug

In period 1, patients will receive a single 125mg oral dose of palbociclib alone. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.

In period 2, subjects will receive 12 daily oral doses of 600mg of rifampin and a single 125mg oral dose of palbociclib on day 8. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.

Other names: palbociclib, PD-0332991

Rifampin

Drug

In period 2, subjects will receive 12 daily oral doses of 600mg of rifampin and a single 125mg oral dose of palbociclib on day 8. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.

Other names: palbociclib, PD-0332991, rifampin, rifampicin

Primary outcomes

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

    Time frame: 0-120 hours post-dose

    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 post-dose

Secondary outcomes

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

    Time frame: 0-120 hours post-dose

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

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

    Time frame: 0-120 hours post-dose

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

    Time frame: 0-120 hours post-dose

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

  4. Apparent Oral Clearance (CL/F)

    Time frame: 0-120 hours post-dose

    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)

    Time frame: 0-120 hours post-dose

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-Label Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Rifampin On Palbociclib (PD-0332991) Pharmacokinetics In Healthy Volunteers

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2013
Registry last updated
Jan 20, 2014

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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