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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Rifampin
Drug: Palbociclib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01953731
A5481017

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Single-Arm Fixed-Sequence
Experimental group
Description:
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.
Treatment:
Drug: Palbociclib
Drug: Rifampin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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