Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 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 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.

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 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.

Trial Locations (1)

06511

New Haven Clinical Research Unit, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02222441 - Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991) | Biotech Hunter | Biotech Hunter