CYP3A4*22Phase 4NCT05691400
Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype
A Phase 4 study testing Palbociclib 125Mg Tab, Ribociclib 200Mg Oral Tablet and Abemaciclib 150 MG Oral Tablet in people with CYP3A4*22, run by University of Michigan Rogel Cancer Center.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CYP3A4*22
- What is being tested?
- Palbociclib 125Mg Tab, Ribociclib 200Mg Oral Tablet and Abemaciclib 150 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age≥18
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- 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
- Carriers 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 team
- History of allergic reaction to CDK4/6 inhibitor
- Pregnancy or nursing female
About this study
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
- Conditions
- CYP3A4*22
- Being tested
- Palbociclib 125Mg Tab, Ribociclib 200Mg Oral Tablet, Abemaciclib 150 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib 125Mg TabDrug
Also called ibrance
125 mg single dose
Ribociclib 200Mg Oral TabletDrug
Also called kisqali
200 mg single dose
Abemaciclib 150 MG Oral TabletDrug
Also called verzenio
150 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| CYP3A4*1/*1 | Experimental | 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. Receives: Drug: Palbociclib 125Mg Tab; Drug: Ribociclib 200Mg Oral Tablet; Drug: Abemaciclib 150 MG Oral Tablet |
| CYP3A4*1/*22 | Experimental | 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. Receives: Drug: Palbociclib 125Mg Tab; Drug: Ribociclib 200Mg Oral Tablet; Drug: Abemaciclib 150 MG Oral Tablet |
| CYP3A4*22/*22 | Experimental | 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. Receives: Drug: Palbociclib 125Mg Tab; Drug: Ribociclib 200Mg Oral Tablet; Drug: Abemaciclib 150 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 62 days after initiation of Study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: funding was not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CYP3A4*22Studies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- arms are designated based off of genotype; however, treatment is the same for each arm
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel L Hertz, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691400
- Sponsor's protocol ID
- UMCC 2022.106
- Other IDs
- HUM00220623
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: will be sharing individual participant data with collaborators at Rochester for analysis only
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype
- ClinicalTrials.gov ID
- NCT05691400
- Acronym / sponsor ID
- UMCC 2022.106
- Conditions
- CYP3A4*22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding was not secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- arms are designated based off of genotype; however, treatment is the same for each arm
| Arm | Type | Receives |
|---|---|---|
| CYP3A4*1/*1 | Experimental | Drug: Palbociclib 125Mg Tab, Drug: Ribociclib 200Mg Oral Tablet, Drug: Abemaciclib 150 MG Oral TabletThis 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. |
| CYP3A4*1/*22 | Experimental | Drug: Palbociclib 125Mg Tab, Drug: Ribociclib 200Mg Oral Tablet, Drug: Abemaciclib 150 MG Oral TabletThis 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. |
| CYP3A4*22/*22 | Experimental | Drug: Palbociclib 125Mg Tab, Drug: Ribociclib 200Mg Oral Tablet, Drug: Abemaciclib 150 MG Oral TabletThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Age≥18
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (5 listed)
- 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
- Carriers 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 team
- History of allergic reaction to CDK4/6 inhibitor
- Pregnancy or nursing female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palbociclib 125Mg TabAlso: ibrance125 mg single dose | Drug | CYP3A4*1/*1, CYP3A4*1/*22, CYP3A4*22/*22 |
| Ribociclib 200Mg Oral TabletAlso: kisqali200 mg single dose | Drug | CYP3A4*1/*1, CYP3A4*1/*22, CYP3A4*22/*22 |
| Abemaciclib 150 MG Oral TabletAlso: verzenio150 mg single dose | Drug | CYP3A4*1/*1, CYP3A4*1/*22, CYP3A4*22/*22 |
Primary outcome
Effect of CYP3A4*22 on the Clearance of Palbociclib
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No. will be sharing individual participant data with collaborators at Rochester for analysis only
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel L Hertz principal investigator
University of Michigan Rogel Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palbociclib 125Mg Tab, Ribociclib 200Mg Oral Tablet and Abemaciclib 150 MG Oral Tablet in people with CYP3A4*22, run by University of Michigan Rogel Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of CYP3A4*22 on the Clearance of Palbociclib (time frame: 2 days after initiation of Palbocicblib treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.