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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-OX-JZQF | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of olomorasib will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olomorasib (Mild Hepatic Impairment) | Experimental | Olomorasib administered orally. |
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| Olomorasib (Moderate Hepatic Impairment) | Experimental | Olomorasib administered orally. |
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| Olomorasib (Severe Hepatic Impairment) | Experimental | Olomorasib administered orally. |
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| Olomorasib (Normal Hepatic Function) | Experimental | Olomorasib administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olomorasib | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib | PK: Cmax of Olomorasib | Predose on Day 1 up to 96 hours postdose |
| PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib | PK: AUC0-inf of Olomorasib | Predose on Day 1 up to 96 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
Females who are lactating or of childbearing potential.
History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor.
History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Clinical Pharmacology of Miami |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
| Miami |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | United States |