A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 7/11/2015 |
| Start Date: | January 2015 |
| End Date: | April 2015 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Open‑Label Fixed‑Sequence 2‑Period Crossover Study Of Palbociclib (pd‑0332991) In Healthy Volunteers To Estimate The Effect Of Antacid Treatment On The Bioavailability Of A 125 Mg Single Dose Of Six Experimental Formulations Of Palbociclib Relative To Palbociclib Administration Alone Under Fasted Conditions
This study will investigate whether concurrent administration of rabeprazole, an antacid
known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given
as one of six experimental formulations.
known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given
as one of six experimental formulations.
This will be a 6 cohort study investigating one experimental formulation of palbociclib in
each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a
fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib
alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In
Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days,
and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a
single 125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood
sampling up to 120 hours post-dose.
each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a
fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib
alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In
Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days,
and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a
single 125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood
sampling up to 120 hours post-dose.
Inclusion Criteria:
- Healthy Male or Female of non-childbearing potential,
- Having a body weight >50 kg
- Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2.
Exclusion Criteria:
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- A positive urine drug or cotinine test
- A known history of hypersensitivity to palbociclib
- A supine systolic blood pressure >140 mmHg, or a QTc >450 msec.
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