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| ID | Type | Description | Link |
|---|---|---|---|
| J2D-JE-CVAD | Other Identifier | Eli Lilly and Company |
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The sponsor made a business decision to withdraw the trial.
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This is a study of LY3526318 in healthy male Japanese. The main purposes of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Dose LY3526318 | Experimental | LY3526318 administered orally in three study periods. |
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| Part A: Single Dose Placebo | Placebo Comparator | Placebo administered orally in three study periods. |
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| Part B: Multiple Dose LY3526318 | Experimental | LY3526318 administered orally. |
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| Part B: Multiple Dose Placebo | Placebo Comparator | Placebo administered orally. |
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| Part C: Iohexol + Simvastatin + Metformin + LY3526318 | Experimental | Iohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3526318 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and B: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through Day 12 |
| Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Metformin | PK: Cmax of metformin. | Predose on Day -2 through Day 8 |
| Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin | PK: AUC of metformin. | Predose on Day -2 through Day 8 |
| Part C: PK: Total Body Clearance (CL) of Iohexol | PK: CL of Iohexol. | Predose on Day -5 through Day 4 |
| Part C: PK: Cmax of Simvastatin | PK: Cmax of simvastatin. | Predose on Day -4 through Day 6 |
| Part C: PK: AUC of Simvastatin | PK: AUC of Simvastatin. | Predose on Day -4 through Day 6 |
| Part C: PK: Cmax of Simvastatin Acid | PK: Cmax of Simvastatin Acid. | Predose on Day -4 through Day 6 |
| Part C: PK: AUC of Simvastatin Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Part A, B, and C: PK: Cmax of LY3526318 | PK: Cmax of LY3526318. | Predose on Day 1 up to Day 14 |
| Part A, B, and C: PK: AUC of LY3526318 | PK: AUC of LY3526318. |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria of Part C:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Souseikai Fukuoka Mirai Hospital | Fukuoka | 813-0017 | Japan |
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| ID | Term |
|---|---|
| D007472 | Iohexol |
| D019821 | Simvastatin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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Part A and B are double blind and Part C is an open-label study.
| Placebo | Drug | Administered orally. |
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| Iohexol | Drug | Administered intravenously (IV). |
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| Simvastatin | Drug | Administered orally. |
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| Metformin | Drug | Administered orally. |
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PK: AUC of Simvastatin Acid. |
| Predose on Day -4 through Day 6 |
| Predose on Day 1 up to Day 14 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |