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

NCT07677358 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C4391014
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hepatic Impairment; Healthy, Hepatic Insufficiency; Healthy Adults

Outcome Measures

Primary Outcomes (4)

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

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

  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 in participants with hepatic impairment

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

  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

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

  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 - ∞).

  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

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

  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 - ∞).

  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

Secondary Outcomes (7)

• Number of Participants With Treatment-Emergent Adverse Events

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

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

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

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

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

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

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

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

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

Study Arms (4)

Group 1: Normal Hepatic Function

EXPERIMENTAL

Atirmociclib administered as a single oral dose

Drug: Atirmociclib

Group 2: Mild Hepatic Impairment

EXPERIMENTAL

Atirmociclib administered as a single oral dose

Drug: Atirmociclib

Group 3: Moderate Hepatic Impairment

EXPERIMENTAL

Atirmociclib administered as a single oral dose

Drug: Atirmociclib

Group 4: Severe Hepatic Impairment

EXPERIMENTAL

Atirmociclib administered as a single oral dose

Drug: Atirmociclib

Interventions

Atirmociclib DRUG

atirmociclib administered as a single oral dose

Also known as: PF-07220060

Group 1: Normal Hepatic Function; Group 2: Mild Hepatic Impairment; Group 3: Moderate Hepatic Impairment; Group 4: Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): August 14, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)