Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib

NCT02131298 | Completed Phase 1

• 1 other identifier: A5481016
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.

Conditions

Healthy

Keywords

Palbociclib; Itraconazole; Pharmacokinetics; Drug-Drug Interaction Study; Healthy Volunteers

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 to 168 hours

• Maximum Observed Plasma Concentration (Cmax)

  0 to 168 hours

Secondary Outcomes (5)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0 to 168 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0 to 168 hours

• Plasma Decay Half-Life (t1/2)

  0 to 168 hours

• Apparent Oral Clearance (CL/F)

  0 to 168 hours

• Apparent Volume of Distribution (Vz/F)

  0 to 168 hours

Study Arms (1)

Fixed sequence

OTHER

Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole)

Drug: Palbociclib Alone; Drug: Palbociclib plus itraconazole

Interventions

Palbociclib Alone DRUG

A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection

Also known as: Palbociclib, PD-0332991

Fixed sequence

Palbociclib plus itraconazole DRUG

Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.

Also known as: Palbociclib (PD-0332991); Itraconazole (Sporanox)

Fixed sequence

Eligibility Criteria

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

You may qualify if:

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
• Body mass index of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases.
• Any condition possibly affecting drug absorption.
• A positive urine drug screen or alcohol breath test.
• Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

palbociclib; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

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: May 2, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

US (1)