A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

Study Overview
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Brief Summary
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The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.

Official Title
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A Phase 1, Randomized, Participant-and Investigator-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose, Drug-Drug Interaction and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3509754 in Healthy Non-Japanese and Japanese Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3509754
* Drug: Placebo
* Drug: Itraconazole
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy males or females, as determined by medical history and physical examination. Body mass index (BMI) within the range of 18 to 35 kilograms per meter squared (kg/m²) in Parts A, B, and C. In Part D (Japanese participants), body weight between 50 and 85 kg and BMI within the range of 18 to 28 kg/m². Exclusion Criteria: Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754. Women of childbearing potential are excluded from the trial.

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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3509754 - Part A<br>Escalating doses of LY3509754 administered orally | Drug: LY3509754<br>* Administered orally<br>|
| Placebo Comparator: Placebo - Part A<br>Placebo administered orally | Drug: Placebo<br>* Administered orally<br>|
| Experimental: LY3509754 plus Itraconazole - Part B<br>LY3509754 and Itraconazole administered orally | Drug: LY3509754<br>* Administered orally<br>Drug: Itraconazole<br>* Administered orally<br>|
| Placebo Comparator: Placebo plus Itraconazole - Part B<br>Placebo and Itraconazole administered orally | Drug: Placebo<br>* Administered orally<br>Drug: Itraconazole<br>* Administered orally<br>|
| Experimental: LY3509754 plus Midazolam - Part C<br>Multiple doses of LY3509754 administered orally. Some participants will also receive midazolam orally. | Drug: LY3509754<br>* Administered orally<br>Drug: Midazolam<br>* Administered orally<br>|
| Placebo Comparator: Placebo plus Midazolam - Part C<br>Multiple doses of placebo administered orally. Some participants will also receive midazolam orally. | Drug: Placebo<br>* Administered orally<br>Drug: Midazolam<br>* Administered orally<br>|
| Experimental: LY3509754 (Japanese) - Part D<br>Multiple doses of LY3509754 administered orally to Japanese participants | Drug: LY3509754<br>* Administered orally<br>|
| Placebo Comparator: Placebo (Japanese) - Part D<br>Placebo administered orally to Japanese participants | 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 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 up to Day 34 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 | PK: Cmax of LY3509754 | Predose up to 96 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3509754 | PK: AUC of LY3509754 | Predose up to 96 hours postdose |