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Not Yet Recruiting NCT05691400

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

Conditions: CYP3A4*22

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 45
Sponsor: University of Michigan Rogel Cancer Center

Summary

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

Eligibility Criteria

Inclusion Criteria:MGI participant with genotype of interest (e.g., CYP3A4*1/*1, CYP3A4*1/*22, or CYP3A4*22/*22) and consented to recontact for future researchAge≥18Ability to understand and the willingness to sign a written informed consent.Exclusion Criteria: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.aspxCarriers another variant known to affect CYP3A4 activity, particularly CYP3A4*20.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 teamHistory of allergic reaction to CDK4/6 inhibitorPregnancy or nursing female

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05691400). StuddyBuddy aggregates publicly available trial information.