Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Healthy
Interventions
DRUG

Palbociclib Alone

A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection

DRUG

Palbociclib plus itraconazole

Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.

Trial Locations (1)

06511

Pfizer Investigational Site, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02131298 - Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib | Biotech Hunter | Biotech Hunter