Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in He... | NCT05691400

NCT05691400

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
HUM00220623	Other Identifier	University Of Michigan

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYP3A41/1	Experimental	This arm will include subjects with CYP3A41/1 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
CYP3A41/22	Experimental	This arm will include subjects with CYP3A41/22 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
CYP3A422/22	Experimental	This arm will include subjects with CYP3A422/22 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.

Name	Type	Description	Arm Group Labels	Other Names
Palbociclib 125Mg Tab	Drug	125 mg single dose	CYP3A41/1 CYP3A41/22 CYP3A422/22

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 days after initiation of Palbocicblib treatment
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.	up to 32 days after initiation of Study drug
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.	up to 62 days after initiation of Study drug

Eligibility Module

ID	Term
C500026	palbociclib
C000589651	ribociclib
D013607	Tablets
C000590451	abemaciclib

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations