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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEN | Other Identifier | Eli Lilly and Company |
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Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.
Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanabecestat Control | Experimental | Lanabecestat administered orally to participants with normal renal function |
|
| Lanabecestat Severe Renal Impairment | Experimental | Lanabecestat administered orally to participants with severe renal impairment, not on dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanabecestat | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat | PK: AUC(0-∞) for Lanabecestat | Baseline through 168 hours after the administration of study drug |
| PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat | PK: Cmax of Lanabecestat | Baseline through 168 hours after the administration of study drug |
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Inclusion Criteria:
- Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)
Exclusion Criteria:
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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 | Tustin | California | 92780 | United States | ||
| Clinical Pharmacology of Miami |
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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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| ID | Term |
|---|---|
| C000608388 | lanabecestat |
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Iohexol | Drug | Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment. |
|
| Miami |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Ctr. | Orlando | Florida | 32809 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |