Healthy
Conditions
Keywords
Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI
Brief summary
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.
Detailed description
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.
Interventions
In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf | Pre-dose to 120 hours post-dose | Area under the concentration-time curve from time zero to infinity. |
| Cmax | Pre-dose to 120 hours post-dose | Maximum observed plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Pre-dose to 120 hours post-dose | Time of the maximum observed concentration post-dose. |
| AUClast | Pre-dose to 120 hours post-dose | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration. |
| t1/2 | Pre-dose to 120 hours post-dose | Terminal phase half-life |
| Vz/F | Pre-dose to 120 hours post-dose | Apparent volume of distribution |
| CL/F | Pre-dose to 120 hours post-dose | Apparent oral clearance from plasma |
Countries
United States
Outcome results
None listed