A Study of LY3873862 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy non-Japanese and Japanese participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 40 and 58 days for part A and B, respectively.

Official Title
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A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3873862
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²) Are male or female participants, including those of childbearing potential For Part B, first-generation Japanese participants who are of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Exclusion Criteria: Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematologic, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation. Are unwilling to comply with the dietary restrictions required for this study, including the avoidance by 5 days prior to study drug administration until the final ambulatory visit the ingestion of fruits, sauces, and juices containing furanocoumarins that irreversibly inhibit cytochrome P450 (CYP)3A4. The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3873862 (Part A)<br>LY3873862 administered orally as single dose. | Drug: LY3873862<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|
| Experimental: LY3873862 (Part B)<br>LY3873862 administered orally as multiple doses. | Drug: LY3873862<br>* Administered orally.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through 98 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862 | PK: AUC[0-∞] of LY3873862 | Predose up to 96 hours postdose | 
| PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862 | PK: (AUCτ) of LY3873862 | Predose up to 96 hours postdose | 
| PK: Maximum Observed Concentration (Cmax) of LY3873862 | PK: Cmax of LY3873862 | Predose up to 96 hours postdose | 
| PK: Time of Maximum observed Concentration (Tmax) of LY3873862 | PK: Tmax of LY3873862 | Predose up to 96 hours postdose |