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| ID | Type | Description | Link |
|---|---|---|---|
| J4X-JE-LWCA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4065967 Part A | Experimental | A single dose of LY4065967 administered orally |
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| Placebo Part A | Placebo Comparator | Placebo administered orally |
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| LY4065967 Part B | Experimental | Multiple doses of LY4065967 administered orally |
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| Placebo Part B | Placebo Comparator | Placebo administered orally |
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| LY4065967 and Rosuvastatin Part D | Experimental | LY4065967 and Rosuvastatin administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4065967 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration | Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline to 7 Days |
| Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration | Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline to 12 Days |
| Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin | Part D: PK: Cmax of Rosuvastatin | Predose on Day 1 Through 72 Hours Post-Dose |
| Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin | Part D: PK: AUC of Rosuvastatin | Predose on Day 1 Through 72 Hours Post-Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 | Part A: PK: Cmax of LY4065967 | Predose on Day 1 Through 48 Hours Post-Dose |
| Part B: PK: Cmax of LY4065967 | Part B: PK: Cmax of LY4065967 |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Souseikai Fukuoka Mirai Hospital | Fukuoka | 813-0017 | Japan |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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Part A and B-Double-blinded Part A3 and D-Open-label
| Placebo | Drug | Administered orally |
|
| Rosuvastatin | Drug | Administered orally |
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| Predose on Day 1 Through Day 9 |
| Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967 | Part A and B: PK: AUC of LY4065967 | Predose on Day 1 Through 48 Hours Post-Dose |
| Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 | Part D: PK: Cmax of LY4065967 | Day 5 Through Day 11 |
| Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967 | Part D: PK: AUC of LY4065967 | Day 5 Through Day 11 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |