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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atirmociclib.
- Who it may be relevant to
- Registry conditions: Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy Adults. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Overview
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.
Interventions
- Drug Atirmociclib
atirmociclib administered as a single oral dose
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Number of Participants With Treatment-Emergent Adverse Events [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib]
- Number of Participants With Normal Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities [Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib]
- Number of Participants With Impaired Hepatic Function having Clinically Significant Electrocardiogram (ECG) Abnormalities [Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 3 centers
- Floridian Clinical Research — Miami Lakes
- Orlando Clinical Research Center — Orlando
- Genesis Clinical Research — Tampa
Identifiers
NCT: NCT07677358 · C4391014