NCT02311946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

December 4, 2014

Last Update Submit

May 27, 2015

Conditions

Healthy

Keywords

Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI

Outcome Measures

Primary Outcomes (2)

  • AUCinf

    Area under the concentration-time curve from time zero to infinity.

    Pre-dose to 120 hours post-dose

  • Cmax

    Maximum observed plasma concentration

    Pre-dose to 120 hours post-dose

Secondary Outcomes (5)

  • AUClast

    Pre-dose to 120 hours post-dose

  • CL/F

    Pre-dose to 120 hours post-dose

  • Tmax

    Pre-dose to 120 hours post-dose

  • Vz/F

    Pre-dose to 120 hours post-dose

  • t1/2

    Pre-dose to 120 hours post-dose

Study Arms (6)

Cohort 1

EXPERIMENTAL

Cohort 1 will receive a 125 mg round yellow palbociclib tablet containing succinic acid

Drug: Palbociclib AloneDrug: Palbociclib + Rabeprazole

Cohort 2

EXPERIMENTAL

Cohort 2 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet containing HMPC E3

Drug: Palbociclib AloneDrug: Palbociclib + Rabeprazole

Cohort 3

EXPERIMENTAL

Cohort 3 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet with HMPC E3 and succinic acid.

Drug: Palbociclib AloneDrug: Palbociclib + Rabeprazole

Cohort 4

EXPERIMENTAL

Cohort 4 will receive a 125 mg oval white/yellow palbociclib bilayer tablet with tartaric and succinic acid.

Drug: Palbociclib AloneDrug: Palbociclib + Rabeprazole

Cohort 5

EXPERIMENTAL

Cohort 5 will receive a 125 mg oval yellow palbociclib fluid bed granulation tablet with succinic acid.

Drug: Palbociclib AloneDrug: Palbociclib + Rabeprazole

Cohort 6

EXPERIMENTAL

Cohort 6 will receive a 125 mg palbociclib oral solution

Drug: Palbociclib AloneDrug: Palbociclib + Rabeprazole

Interventions

Palbociclib AloneDRUG

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.

Also known as: Palbociclib, PD-0332991
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6
Palbociclib + RabeprazoleDRUG

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.

Also known as: Palbociclib, PD-0332991, Rabeprazole, Aciphex, Proton Pump Inhibitor, PPI
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

MRA Clinical Research - Phase 1

Miami, Florida, 33143, United States

Location

Miami Research Associates, LLC

South Miami, Florida, 33143, United States

Location

MRA Clinical Research, LLC

South Miami, Florida, 33143, United States

Location

MeSH Terms

Interventions

palbociclibRabeprazoleProton Pump Inhibitors

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(3)