A Study of LY3410738 in Healthy Adult Participants

Study Overview
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Brief Summary
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The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.

Official Title
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A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3410738
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator Female participants of non-childbearing potential and male participants who follow standard contraceptive methods Must comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call Exclusion Criteria: History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening. Positive polymerase chain reaction (PCR) test for COVID-19 at Screening Known ongoing alcohol and/or drug abuse within 2 years prior to Screening History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Cohort 1 (Treatment A): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. | Drug: LY3410738<br>* Administered orally.<br>Drug: Placebo<br>* Administered orally.<br>|
| Placebo Comparator: Cohort 2 (Treatment B): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. | Drug: LY3410738<br>* Administered orally.<br>Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Cohort 3 (Treatment C): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. | Drug: LY3410738<br>* Administered orally.<br>Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Cohort 4 (Treatment D): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. | Drug: LY3410738<br>* Administered orally.<br>Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Cohort 5 (Treatment E): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. | Drug: LY3410738<br>* Administered orally.<br>Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Cohort 6 (Treatment F): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. | Drug: LY3410738<br>* Administered orally.<br>Drug: Placebo<br>* Administered orally.<br>|
| Experimental: Cohort 7 (Treatment G): LY3410738<br>Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. | Drug: LY3410738<br>* Administered orally.<br>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 53 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738 | PK: AUC0-24 of LY3410738 | Pre-dose up to 24 hours post-dose | 
| PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738 | PK: AUC0-t of LY3410738 | Pre-dose up to 48 hours post-dose | 
| PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 | PK: Cmax of LY3410738 | Pre-dose up to 48 hours post-dose | 
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738 | PK: Tmax of LY3410738 | Pre-dose up to 48 hours post-dose |