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

NCT02097329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-06-19

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

palbociclib commercial free base

125 mg oral capsule single dose

DRUG

famotidine

20 mg oral tablet 10 hours before and 2 hours after palbociclib

DRUG

rabeprazole

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

DRUG

palbociclib commercial free base

125 mg oral capsule single dose

DRUG

antacid

30 mL orally once (2h before palbociclib)

DRUG

antacid

30 mL orally once (2h after palbociclib)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097329 on ClinicalTrials.gov