Recruiting
Phase 1

Atirmociclib

Sponsor:

Pfizer

Code:

NCT07677358

Conditions

Hepatic Impairment

Healthy, Hepatic Insufficiency

Healthy Adults

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Atirmociclib

Study Details

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

Study ID

NCT07677358

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Sep 10, 2027

Anticipated

Primary completion date

Aug 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group 1: Normal Hepatic Function

Atirmociclib administered as a single oral dose

experimental: Group 4: Severe Hepatic Impairment

Atirmociclib administered as a single oral dose

experimental: Group 3: Moderate Hepatic Impairment

Atirmociclib administered as a single oral dose

experimental: Group 2: Mild Hepatic Impairment

Atirmociclib administered as a single oral dose

Interventions

Atirmociclib

atirmociclib administered as a single oral dose

Primary outcome measure

  • 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 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Genesis Clinical Research

Recruiting

Tampa, Florida, United States, 33603

More Information

Sponsor

Pfizer

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-21.