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.
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.
Any condition or history of surgery possibly affecting drug absorption.
Use of prohibited prior or concomitant medications.
Parallel
Atirmociclib
Drugatirmociclib administered as a single oral dose
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
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
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 - ∞).
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 - ∞).
Number of Participants With Treatment-Emergent Adverse Events
Number of Participants With Normal Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities
Number of Participants With Impaired Hepatic Function having Clinically Significant Clinical Laboratory Abnormalities
Number of Participants With Normal Hepatic Function having Clinically Significant Change From Baseline in Vital Signs
