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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-OX-JZQG | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to help determine the right dose of LY3537982 in participants with kidney problems, particularly those with severe kidney problems. The study will last about 43 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537982 (Normal renal function) | Experimental | LY3537982 administered orally. |
|
| LY3537982 (Severe renal impairment) | Experimental | LY3537982 administered orally. |
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| LY3537982 (Moderate renal impairment) | Experimental | LY3537982 administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537982 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3537982 | Day 1, Predose up to Day 5 Postdose | |
| Pharmacokinetics: Area Under the Concentration Verses Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3537982 | Day 1, Predose up to Day 5 Postdose | |
| Pharmacokinetics: Area Under the Concentrations Verses Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3537982 | Day 1, Predose up to Day 5 Postdose |
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Inclusion Criteria:
Exclusion Criteria:
Have history of chronic liver disease, or any evidence for hepatic impairments, or
* ALT or AST greater than 2.5 × ULN without any increase in TBL or * TBL greater than 1.5 × ULN without any increase in aminotransferase.
Have a current, functional renal transplant. Non-functional renal allografts may be allowed if failure has been greater than 1 year and no longer on immunosuppressive therapies.
Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix
Have known allergies to LY3537982, related compounds or any components of the formulation, or a history of significant atopy.
Have previously completed or withdrawn from this study or any other study investigating LY3537982.
Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer should have passed, prior to admission
Show evidence of HIV infection or positive human HIV antibodies.
Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, HBV DNA, or both.
Have a positive hepatitis C antibody test. Participants with a positive hepatitis C antibody test at screening can be included only if a confirmatory HCV RNA test is negative.
Are participants AFAB with a positive pregnancy test or who are lactating. ssion onward, up to 2 g per day of acetaminophen will be allowed at the discretion of the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States | ||
| Panax Clinical Research |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Genesis Clinical Research | Tampa | Florida | 33603 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |