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

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Study 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.

  Drug: Palbociclib 125Mg Tab · Drug: Ribociclib 200Mg Oral Tablet · Drug: Abemaciclib 150 MG Oral Tablet

• 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 · Drug: Ribociclib 200Mg Oral Tablet · Drug: Abemaciclib 150 MG Oral Tablet

• 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 · Drug: Ribociclib 200Mg Oral Tablet · Drug: Abemaciclib 150 MG Oral Tablet

Interventions

• DrugPalbociclib 125Mg Tab

  125 mg single dose

  Also known as: ibrance

• DrugRibociclib 200Mg Oral Tablet

  200 mg single dose

  Also known as: kisqali

• DrugAbemaciclib 150 MG Oral Tablet

  150 mg single dose

  Also known as: verzenio

Primary outcomes

1. Effect of CYP3A4*22 on the Clearance of Palbociclib

   To determine the effect of CYP3A4\*22 on the Clearance of Palbociclib when administered as a single dose to healthy volunteers.

   Time frame: 2 days after initiation of Palbocicblib treatment

2. Effect of CYP3A4*22 on the Clearance of Ribociclib

   To determine the effect of CYP3A4\*22 on the Clearance of Ribociclib when administered as a single dose to healthy volunteers.

   Time frame: up to 32 days after initiation of Study drug

3. Effect of CYP3A4*22 on the CL of Abemaciclib

   To determine the effect of CYP3A4\*22 on the Clearance of Abemaciclib when administered as a single dose to healthy volunteers.

   Time frame: up to 62 days after initiation of Study drug

Individual participant data

Plan to share: No — will be sharing individual participant data with collaborators at Rochester for analysis only