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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Normal Hepatic Function | Experimental | Atirmociclib administered as a single oral dose |
|
| Group 2: Mild Hepatic Impairment | Experimental | Atirmociclib administered as a single oral dose |
|
| Group 3: Moderate Hepatic Impairment | Experimental | Atirmociclib administered as a single oral dose |
|
| Group 4: Severe Hepatic Impairment | Experimental | Atirmociclib administered as a single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atirmociclib | Drug | atirmociclib administered as a single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Maximum observed plasma concentration (Cmax) for atirmociclib following a single oral dose in participants with hepatic impairment | 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 | 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 - ∞). | 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 | 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 - ∞). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | 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 |
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Inclusion criteria including but not limited to:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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|
| 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 | 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 | 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 | 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 | 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 | Predose and at 4, 192 hours after a single oral dose of atirmociclib |
| Orlando |
| Florida |
| 32809 |
| United States |
| Genesis Clinical Research | Tampa | Florida | 33603 | United States |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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