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

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)

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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