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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05691400

Enrollment

Registered

2023-01-20

Start date

2024-03-31

Completion date

2027-03-31

Last updated

2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYP3A4*22

Brief 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

Interventions

DRUGPalbociclib 125Mg Tab

125 mg single dose

DRUGRibociclib 200Mg Oral Tablet

200 mg single dose

DRUGAbemaciclib 150 MG Oral Tablet

150 mg single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

arms are designated based off of genotype; however, treatment is the same for each arm

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Effect of CYP3A4*22 on the Clearance of Palbociclib	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.
Effect of CYP3A4*22 on the Clearance of Ribociclib	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.
Effect of CYP3A4*22 on the CL of Abemaciclib	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026