Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype
NCT ID: NCT05691400
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2024-03-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Palbociclib 125Mg Tab
125 mg single dose
Ribociclib 200Mg Oral Tablet
200 mg single dose
Abemaciclib 150 MG Oral Tablet
150 mg single dose
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.
Palbociclib 125Mg Tab
125 mg single dose
Ribociclib 200Mg Oral Tablet
200 mg single dose
Abemaciclib 150 MG Oral Tablet
150 mg single dose
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.
Palbociclib 125Mg Tab
125 mg single dose
Ribociclib 200Mg Oral Tablet
200 mg single dose
Abemaciclib 150 MG Oral Tablet
150 mg single dose
Interventions
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Palbociclib 125Mg Tab
125 mg single dose
Ribociclib 200Mg Oral Tablet
200 mg single dose
Abemaciclib 150 MG Oral Tablet
150 mg single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age≥18
3. Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Daniel L Hertz
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Other Identifiers
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HUM00220623
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2022.106
Identifier Type: -
Identifier Source: org_study_id
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