Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: antacid; Drug: famotidine; Drug: palbociclib commercial free base; Drug: rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097329

A5481038

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

Cohort 1: Palbociclib under fed conditions

Experimental group

Treatment:

Drug: rabeprazole

Drug: palbociclib commercial free base

Drug: famotidine

Drug: palbociclib commercial free base

Cohort 2: Palbociclib under fed conditions

Experimental group

Treatment:

Drug: antacid

Drug: palbociclib commercial free base

Drug: palbociclib commercial free base

Drug: antacid