NCT01953731

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

September 26, 2013

Last Update Submit

January 16, 2014

Conditions

Healthy

Keywords

palbociclibPD-0332991rifampindrug-drug interaction study

Outcome Measures

Primary Outcomes (2)

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

    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).

    0-120 hours post-dose

  • Maximum Observed Plasma Concentration (Cmax)

    0-120 hours post-dose

Secondary Outcomes (5)

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

    0-120 hours post-dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0-120 hours post-dose

  • Plasma Decay Half-Life (t1/2)

    0-120 hours post-dose

  • Apparent Oral Clearance (CL/F)

    0-120 hours post-dose

  • Apparent Volume of Distribution (Vz/F)

    0-120 hours post-dose

Study Arms (1)

Single-Arm Fixed-Sequence

EXPERIMENTAL

Subjects will receive two different interventions in fixed-sequence two-period study. In the first period the subjects will receive a single-dose of palbociclib. In the second period, subjects will receive 12 days of rifampin and a single dose of palbociclib on day 8. In both periods, subjects will undergo pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.

Drug: PalbociclibDrug: Rifampin

Interventions

PalbociclibDRUG

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.

Also known as: palbociclib, PD-0332991
Single-Arm Fixed-Sequence
RifampinDRUG

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.

Also known as: palbociclib, PD-0332991, rifampin, rifampicin
Single-Arm Fixed-Sequence

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Interventions

palbociclibRifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 1, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

US(1)