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NCT Number: 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

The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.

The study is seeking participants who are:

* Aged 18 years or older * Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg. * Have normal liver function or have stable mild, moderate, or severe liver disease

Participants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.

Participants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Floridian Clinical Research, Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

including but not limited to:

  • 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.

Normal hepatic function group only:

  • Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.

Hepatic impairment groups only:

  • Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.

Exclusion criteria

including but not limited to:

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

Normal hepatic function group only:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Hepatic impairment groups only:

  • A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.

Treatment and study plan

Atirmociclib

Drug

atirmociclib administered as a single oral dose

Other names: PF-07220060

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with normal hepatic function

    Time frame: 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

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

  2. Maximum Observed Plasma Concentration (Cmax) for atirmociclib in participants with hepatic impairment

    Time frame: Pre-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

  3. Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with normal hepatic function

    Time frame: 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

    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 - ∞).

  4. Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for atirmociclib in participants with impaired hepatic function

    Time frame: Pre-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 - ∞).

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of atirmociclib

  2. Number of Participants With Normal Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities

    Time frame: Baseline and Day 2, Day 7 after a single oral dose of atirmociclib

  3. Number of Participants With Impaired Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities

    Time frame: Baseline and Day 2, Day 9 after a single oral dose of atirmociclib

  4. Number of Participants With Normal Hepatic Function having Clinically Significant Change From Baseline in Vital Signs

    Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib

  5. Number of Participants With Impaired Hepatic function having Clinically Significant Change From Baseline in Vital Signs

    Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib

  6. Number of Participants With Normal Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities

    Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib

  7. Number of Participants With Impaired Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities

    Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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