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Atirmociclib Study for Liver Function

This study is looking at how the medicine called Atirmociclib is handled by the body in people with normal liver function and those with different levels of liver disease. We want to understand how safe Atirmociclib is and if liver disease changes how the body processes it. You may be able to join if you are 18 or older, weigh over 110 lbs, and have a BMI between 17.5 and 40. You can have normal liver function or stable mild, moderate, or severe liver disease. Participants will take a single dose of Atirmociclib by mouth, and blood samples will be collected over time to measure the medicine in your body. The study aims to see how the amount of medicine in the blood (Cmax and AUC) changes based on liver health.

Study design
This is an interventional study planning to enroll 28 participants, including healthy adults and those with hepatic impairment.
What's involved
You will receive Atirmociclib as a single oral dose. Blood samples will be collected at specific times for up to 192 hours. The study will last about 9 weeks, with clinic stays of about 7 days for those with normal liver function and about 9 days for those with liver disease.
Compensation
Not stated in the trial record.
Follow-up
Blood samples will be collected for up to 144 hours for participants with normal liver function and up to 192 hours for those with hepatic impairment after the single dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07677358

A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease

Recruiting
PHASE1Ages 18+Interventional
Pfizer
~28 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Atirmociclib

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function
Measured over Pre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose
+3 more outcomes measured

Conditions

Hepatic Impairment
Healthy, Hepatic Insufficiency
Healthy Adults

Explore related trials

Healthy VolunteersLiver Failure

NCT07677358

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Floridian Clinical Research

    Miami Lakes, Floridano site contact published

    Recruiting

  • Genesis Clinical Research

    Tampa, Floridano site contact published

    Recruiting

  • Orlando Clinical Research Center

    Orlando, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Eligibility criteria

Inclusion

BMI of 17.5-40 kg/m2; and a total body weight \>50 kg (110 lb).
Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Capable of giving signed informed consent.

Exclusion

Any condition or history of surgery possibly affecting drug absorption.
Use of prohibited prior or concomitant medications.

What this trial measures

  • Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic functionPre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose

    Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with normal hepatic function

  • Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with hepatic impairmentPre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose

    Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with hepatic impairment

  • Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with normal hepatic functionPre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144 hours after a single oral dose

    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

  • Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with impaired hepatic functionPre-dose and at, 1, 2, 4, 6, 8, 12, and 24, 36, 48, 60, 72, 96, 120, 144, 168, 192 hours after a single oral dose

    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).