A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/1/2014 |
| Start Date: | October 2013 |
| End Date: | December 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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
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.
palbociclib in the presence and absence of rifampin-mediated enzyme induction in a
fixed-sequence two-period study.
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
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