Atirmociclib
Drugatirmociclib administered as a single oral dose
Other names: PF-07220060
NCT Number: NCT07677358
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1
Floridian Clinical Research, Miami Lakes, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
including but not limited to:
Normal hepatic function group only:
Hepatic impairment groups only:
Exclusion criteria
including but not limited to:
Normal hepatic function group only:
Hepatic impairment groups only:
atirmociclib administered as a single oral dose
Other names: PF-07220060
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 following a single oral dose 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, 168, 192 hours after a single oral dose
Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose 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 hours after a single oral dose
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 - ∞).
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
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 - ∞).
Time frame: Time from baseline through and including follow-up contact occurring 28 to 35 calendar days after the last administration of atirmociclib
Time frame: Baseline and Day 2, Day 7 after a single oral dose of atirmociclib
Time frame: Baseline and Day 2, Day 9 after a single oral dose of atirmociclib
Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib
Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Time frame: Predose and at 4, 144 hours after a single oral dose of atirmociclib
Time frame: Predose and at 4, 192 hours after a single oral dose of atirmociclib
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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