14
Participants
Start Date
October 31, 2014
Primary Completion Date
December 31, 2014
Study Completion Date
December 31, 2014
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.
Palbociclib plus Modafinil
For Cohort 1, modafinil 200 mg once daily for 7 days, followed by 400 mg once daily for 25 days; on Day 28, a single oral 125 mg dose of palbociclib will be given with modafinil after a meal, followed by 120 hours of PK sample collection.
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.
Palbociclib plus pioglitazone
For Cohort 2, pioglitazone 45 mg once daily for a total of 19 days; On Day 15, a single oral 125 mg dose of palbociclib will be given with pioglitazone after a meal, followed by 120 hours of PK sample collection.
New Haven Clinical Research Unit, New Haven
Lead Sponsor
Pfizer
INDUSTRY