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

Healthy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:palbociclib commercial free base125 mg oral capsule single dose

Drug:famotidine20 mg oral tablet 10 hours before and 2 hours after palbociclib

Drug:rabeprazole2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib

Drug:palbociclib commercial free base125 mg oral capsule single dose

Drug:antacid30 mL orally once (2h before palbociclib)

Drug:antacid30 mL orally once (2h after palbociclib)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cohort 1: Palbociclib under fed conditions

Cohort 2: Palbociclib under fed conditions

Study Status

Completed

Start Date: April 2014

Completed Date: June 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

Secondary Outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02097329

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