How the medicine Atirmociclib behaves in people with healthy liver or with liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, interventional study examines the pharmacokinetics and safety of atirmociclib in adults with normal liver function or stable hepatic impairment. Participants receive the drug by mouth and provide blood samples over time to see how liver health affects drug exposure. The study lasts about 9 weeks, with a clinic stay of 7–9 days depending on liver status, followed by potential follow-up contacts. The goal is to understand whether liver disease changes how the medicine is handled in the body and to ensure safety across liver health groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Floridian Clinical Research
  Miami Lakes, Florida, United States Recruiting
• Orlando Clinical Research Center
  Orlando, Florida, United States Recruiting
• Genesis Clinical Research
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.