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

Conditions

• CYP3A4*22

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Palbociclib 125Mg Tab — DRUG
  125 mg single dose
• Ribociclib 200Mg Oral Tablet — DRUG
  200 mg single dose
• Abemaciclib 150 MG Oral Tablet — DRUG
  150 mg single dose

Study Details

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

Key Dates

First listed

Jan 20, 2023

Start date

Mar 31, 2024

Status verified

Feb 2024

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

Effect of CYP3A4*22 on the Clearance of Palbociclib [ Time Frame: 2 days after initiation of Palbocicblib treatment ]