Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)

NCT01918176 | Completed Phase 1

• 1 other identifier: A5481018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption process of Palbociclib.

Conditions

Healthy

Keywords

Palbociclib; PD-0332991; Proton Pump Inhibitor; DDI; Healthy Volunteers; Pharmacokinetics; Rabeprazole

Outcome Measures

Primary Outcomes (2)

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

  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).

  0-120 hours

• Maximum Observed Plasma Concentration (Cmax)

  0-120 hours

Secondary Outcomes (7)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

  0-120 hours

• Area Under the Curve from Time Zero to 72 hours

  0-72 hours

• Apparent Oral Clearance (CL/F)

  0-120 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0-120 hours

• Time For the Last Quantifiable Concentration (Tlast)

  0-120 hours

Study Arms (1)

Fixed sequence crossover

EXPERIMENTAL

All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole.

Drug: Palbociclib alone; Drug: Palbociclib + Rabeprazole

Interventions

Palbociclib alone DRUG

Single dose of 125mg Palbociclib capsule will be administered to subjects orally and then PK samples will be collected at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.

Also known as: Period 1

Fixed sequence crossover

Palbociclib + Rabeprazole DRUG

Two Rabeprazole 20mg tablets will be given to subjects orally once daily for 7 days. Then on the same day at least 4 hours after the last dose of Rabeprazole, single dose of 125mg Palbociclib capsule will be given to subjects orally then followed by PK samplings at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.

Also known as: Period 2

Fixed sequence crossover

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects of non-childbearing potential; Healthy subjects identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test.

You may not qualify if:

• A positive urine drug screen, urine cotinine test or alcohol breath test.
• Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication. All antacid agents must be discontinued 28 days prior to the first dose of study medication.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

palbociclib; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 7, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

US (1)