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

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Pfizer
Study ID
NCT07677358
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Adults
  • Healthy, Hepatic Insufficiency
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Atirmociclib — DRUG
    atirmociclib administered as a single oral dose

Study Details

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.

Key Dates

Start date
Jul 9, 2026
Status verified
Jun 2026
Primary completion
Aug 14, 2027
Completion
Sep 10, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Group 1: Normal Hepatic Function
    Atirmociclib administered as a single oral dose
  • Experimental: Group 2: Mild Hepatic Impairment
    Atirmociclib administered as a single oral dose
  • Experimental: Group 3: Moderate Hepatic Impairment
    Atirmociclib administered as a single oral dose
  • Experimental: Group 4: Severe Hepatic Impairment
    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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Floridian Clinical ResearchMiami LakesFlorida33016-
Orlando Clinical Research CenterOrlandoFlorida32809-
Genesis Clinical ResearchTampaFlorida33603-

Find similar trials in Miami Lakes, FL

By research site
Floridian Clinical Research· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLGenesis Clinical Research· Tampa, FL

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