Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype

February 1, 2024 updated by: University of Michigan Rogel Cancer Center
The objective of this study is to estimate the effect of CYP3A4*22 on the clearance and area under the plasma concentration-time curve of Palbociclib, Ribociclib, and Abemaciclib

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. MGI participant with genotype of interest (e.g., CYP3A4*1/*1, CYP3A4*1/*22, or CYP3A4*22/*22) and consented to recontact for future research
  2. Age≥18
  3. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. Concurrent use of a moderate or strong inhibitor or inducer of CYP3A4, based on the current version of the Drug Interactions Flockhart Table™, available at this link or by google search: https://drug-interactions.medicine.iu.edu/MainTable.aspx
  2. Carriers another variant known to affect CYP3A4 activity, particularly CYP3A4*20.
  3. Active malignancy or other disease state that would affect the pharmacokinetics of CDK4/6 inhibitors or place the participant at particular risk of toxicity from a single dose of a CDK4/6 inhibitor, in the opinion of the study team
  4. History of allergic reaction to CDK4/6 inhibitor
  5. Pregnancy or nursing female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYP3A4*1/*1

This arm will include subjects with CYP3A4*1/*1 genotype. They will receive a single oral dose of each CDK4/6 inhibitor on separate days, with at least 6 days and no more than 30 days between each medication. All participants will receive the medications in the same order: Palbociclib, Ribociclib, Abemaciclib

Ribociclib- 200 mg tablet Abemaciclib- 150 mg tablet Palbociclib-125 mg tablet

PK sampling will be done at the time of drug administration and at different time points until 48 hours post administration.
Drug: Palbociclib 125Mg Tab
125 mg single dose
Other Names:
  • ibrance
Drug: Ribociclib 200Mg Oral Tablet
200 mg single dose
Other Names:
  • kisqali
Drug: Abemaciclib 150 MG Oral Tablet
150 mg single dose
Other Names:
  • verzenio
Experimental: CYP3A4*1/*22

This arm will include subjects with CYP3A4*1/*22 genotype. They will receive a single oral dose of each CDK4/6 inhibitor on separate days, with at least 6 days and no more than 30 days between each medication. All participants will receive the medications in the same order: Palbociclib, Ribociclib, Abemaciclib

Ribociclib- 200 mg tablet Abemaciclib- 150 mg tablet Palbociclib-125 mg tablet

PK sampling will be done at the time of drug administration and at different time points until 48 hours post administration.
Drug: Palbociclib 125Mg Tab
125 mg single dose
Other Names:
  • ibrance
Drug: Ribociclib 200Mg Oral Tablet
200 mg single dose
Other Names:
  • kisqali
Drug: Abemaciclib 150 MG Oral Tablet
150 mg single dose
Other Names:
  • verzenio
Experimental: CYP3A4*22/*22

This arm will include subjects with CYP3A4*22/*22 genotype. They will receive a single oral dose of each CDK4/6 inhibitor on separate days, with at least 6 days and no more than 30 days between each medication. All participants will receive the medications in the same order: Palbociclib, Ribociclib, Abemaciclib

Ribociclib- 200 mg tablet Abemaciclib- 150 mg tablet Palbociclib-125 mg tablet

PK sampling will be done at the time of drug administration and at different time points until 48 hours post administration.
Drug: Palbociclib 125Mg Tab
125 mg single dose
Other Names:
  • ibrance
Drug: Ribociclib 200Mg Oral Tablet
200 mg single dose
Other Names:
  • kisqali
Drug: Abemaciclib 150 MG Oral Tablet
150 mg single dose
Other Names:
  • verzenio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of CYP3A4*22 on the Clearance of Palbociclib
Time Frame: 2 days after initiation of Palbocicblib treatment
To determine the effect of CYP3A4*22 on the Clearance of Palbociclib when administered as a single dose to healthy volunteers.
2 days after initiation of Palbocicblib treatment
Effect of CYP3A4*22 on the Clearance of Ribociclib
Time Frame: up to 32 days after initiation of Study drug
To determine the effect of CYP3A4*22 on the Clearance of Ribociclib when administered as a single dose to healthy volunteers.
up to 32 days after initiation of Study drug
Effect of CYP3A4*22 on the CL of Abemaciclib
Time Frame: up to 62 days after initiation of Study drug
To determine the effect of CYP3A4*22 on the Clearance of Abemaciclib when administered as a single dose to healthy volunteers.
up to 62 days after initiation of Study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Daniel L Hertz, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2022.106
  • HUM00220623 (Other Identifier: University Of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

will be sharing individual participant data with collaborators at Rochester for analysis only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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