Atirmociclib for Healthy Subjects

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: CYP3A4, UGT2B7 inducers

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different doses of a new medicine, atirmociclib, behave in the body when taken with food. It seeks healthy men and women with a body weight over 110 pounds and a BMI between 17.5 and 30.5. Participants will help researchers determine the safety and processing of different doses of the medication. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

You may need to stop taking certain medications if they strongly affect specific liver enzymes (CYP3A4 or UGT2B7) up to 28 days before the trial starts. Otherwise, the protocol does not specify stopping other medications.

Is there any evidence suggesting that atirmociclib is likely to be safe for humans?

Research has shown that atirmociclib is still under study to determine its safety and tolerability. As this is an early-stage study, the primary goal is to assess the safety of atirmociclib at various doses in humans. Limited information is available, so it is normal to have uncertainties about side effects and individual reactions.

Participants in such studies help researchers identify any side effects, which are unexpected effects that can occur with a new medicine. So far, no serious safety issues have been reported, but more information will emerge as the study progresses.

By joining, participants contribute to researchers' understanding of atirmociclib and its safety. It is important to recognize that all new treatments involve some uncertainties, and participants' health will be closely monitored throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Atirmociclib is unique because it targets CDK9, a protein involved in regulating cell cycle progression and transcription. Most existing treatments for conditions involving abnormal cell growth focus on other targets, like CDK4/6, making Atirmociclib a novel approach. Researchers are excited about its potential to offer a more precise and effective treatment by interfering with different cellular processes. Additionally, the higher drug load IR MST tablet form could improve delivery and absorption, potentially enhancing its efficacy and reducing side effects compared to current options.

What evidence suggests that atirmociclib could be effective?

Research has shown that atirmociclib has potential based on early lab studies, where it helped fight tumors and worked well with other cancer treatments. This drug specifically targets a protein called CDK4, which is involved in cell growth and division. Initial studies in patients with certain types of breast cancer found that atirmociclib, when used with hormone therapy, was safe and effective against the cancer. These results suggest that atirmociclib could be a promising option for treating cancers that depend on CDK4 for growth. This trial will study different doses of atirmociclib in healthy subjects to further understand its safety and pharmacokinetics. ^{2 5 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This study is for healthy men and women aged 18 to 65, with a BMI of 17.5-30.5 kg/m2 and weighing over 50 kg (110 lbs.). Participants must pass medical evaluations including history, physical exams, and lab tests.

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests

Body mass Index (BMI) of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb.)

Exclusion Criteria

I have never taken atirmociclib or been in studies requiring its use.

I haven't taken strong CYP3A4 or UGT2B7 affecting drugs recently.

I have a condition that might affect how my body absorbs medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Period 1

Participants receive atirmociclib at Dose A, B, C, or D in one of the 12 treatment sequences among 6 cohorts under fed conditions

6 days

In-patient stay for 6 days

Washout

Minimum 7-day interval between Treatment Period 1 and Treatment Period 2

7 days

Treatment Period 2

Participants receive atirmociclib at a different dose in the shuffled sequence under fed conditions

6 days

In-patient stay for 6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atirmociclib

Trial Overview The trial is testing the drug atirmociclib's pharmacokinetics—how it's absorbed, distributed, metabolized, and excreted in different doses after eating. All participants will try four dose levels in various sequences across two periods.

How Is the Trial Designed?

Group I: Cohort 6 Experimental Treatment 1 Intervention

In Period 1 Day 1, participants from Sequence CD and DC will receive Dose C and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Group II: Cohort 5 Experimental Treatment 1 Intervention

In Period 1 Day 1, participants from Sequence BD and DB will receive Dose B and Dose D atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Group III: Cohort 4 Experimental Treatment 1 Intervention

In Period 1 Day 1, participants from Sequence AD and DA will receive Dose A and Dose D atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Group IV: Cohort 3 Experimental Treatment 1 Intervention

In Period 1 Day 1, participants from Sequence BC and CB will receive Dose B and Dose C atirmociclib higher drug load IR MST tablets, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Group V: Cohort 2 Experimental Treatment 1 Intervention

In Period 1 Day 1, participants from Sequence AC and CA will receive Dose A and Dose C atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Group VI: Cohort 1 Experimental Treatment 1 Intervention

In Period 1 Day 1, participants from Sequence AB and BA will receive Dose A and Dose B atirmociclib higher drug load IR MST tablet, respectively. In Period 2 Day 1, the participants from two sequences in the same cohort will shuffle the treatment.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07215078

Study About Whether Atirmociclib/PF-07220060 ... The purpose of this clinical trial is to learn about the dose proportionality on the PK of the study medicine (called atirmociclib) when ...

2. esmoopen.com esmoopen.com/article/S2059-7029(25)00513-7/fulltext

90P Effect of atirmociclib plus endocrine therapy (ET) on ... Atirmociclib + ET demonstrated favorable safety, tolerability, clinical activity, and robust pharmacodynamic (PD) activities in patients (pts) with HR+/HER2− ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12424423/

Real-world progression-free survival of CDK4/6 inhibitors ... We observed no statistically significant differences in rwPFS in patients with HR-positive/HER2-negative mBC receiving 1L palbociclib, ribociclib, or ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/35744174/pfizers-new-study-on-atirmociclib-a-potential-game-changer/

Pfizer's New Study on Atirmociclib: A Potential Game ... ' The study aims to assess how the pharmacokinetics of atirmociclib, a drug under investigation, varies with different doses in healthy ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1535610825000583

CDK4 selective inhibition improves preclinical anti-tumor ... Our data indicate that atirmociclib induces greater anti-tumor immunity and sensitization to immune checkpoint inhibition than palbociclib.

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-9ff6d

Atirmociclib for Healthy Subjects · Info for Participants This Phase 1 medical study run by Pfizer needs participants to evaluate whether Atirmociclib will have tolerable side effects & efficacy for patients with ...

7. pfizeroncologydevelopment.com pfizeroncologydevelopment.com/clinical_trial/NCT06465368

Atirmociclib (PF-07220060) Atirmociclib | PF-07220060 is an investigational compound. Its safety and efficacy have not been established. AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, ...

8. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-139450/Atirmociclib-SDS-MedChemExpress.pdf

Safety Data Sheet Prevention. P264 Wash hands thoroughly after handling. P280 Wear protective gloves/protective clothing/eye protection/face protection. Response.