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| ID | Type | Description | Link |
|---|---|---|---|
| J5H-MC-KVAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3867070 (Part A) | Experimental | Single-Ascending Dose of LY3867070 administered orally |
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| LY3867070 (Part B) | Experimental | Multiple-Ascending Doses of LY3867070 administered orally |
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| LY3867070 (Part C) | Experimental | Multiple Doses of LY3867070 administered orally |
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| Placebo (Parts A-C) | Placebo Comparator | Placebo administered orally |
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| LY3867070 (Part D) | Experimental | Drug-Drug Interaction (DDI) administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3867070 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Approximately Week 7 |
| 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 regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Approximately Week 7 |
| Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of AEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Approximately Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070 | PK: AUC of LY3867070 | Baseline up to Approximately Week 7 |
| PK: Maximum Concentration (Cmax) of LY3867070 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Recruiting | Anaheim | California | 92801 | United States |
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Parts A, B, and C are parallel. Part D is open-label fixed-sequence.
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Part D will be open-label
| Placebo | Drug | Administered orally |
|
PK: Cmax of LY3867070
| Baseline up to Approximately Week 7 |
| Part B Pharmacodynamic (PD): Change from Baseline in Gene Expression | PD: Change from Baseline in Gene Expression | Baseline up to Approximately Week 6 |
| Fortrea Clinical Research Unit | Recruiting | Dallas | Texas | 75247 | United States |
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