Healthy
Conditions
Keywords
bioavailability, antacid, rabeprazole, famotidine, palbociclib
Brief summary
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
Interventions
DRUGpalbociclib commercial free base
125 mg oral capsule single dose
DRUGfamotidine
20 mg oral tablet 10 hours before and 2 hours after palbociclib
DRUGrabeprazole
2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
DRUGantacid
30 mL orally once (2h before palbociclib)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
* Evidence or history of clinically significant diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease). * Use of tobacco or nicotine containing products within 3 months of screening. * A positive urine drug screen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 6 days | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). |
| Maximum Observed Plasma Concentration (Cmax) | 6 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 6 days | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 6 days | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Plasma Decay Half-Life (t1/2) | 6 days | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Apparent Volume of Distribution (Vz/F) | 6 days | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
| Apparent Oral Clearance (CL/F) | 6 days | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
Countries
United States
Outcome results
None listed