A Multiple Dose Study of LY3502970 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.

Official Title
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A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3502970
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy as determined by medical evaluation. Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²). Exclusion Criteria: Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2X ULN (Upper Limit of Normal) Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study Are women of child-bearing potential Are women who are lactating

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3502970 Prototype (Part A)<br>Multiple doses of LY3502970 prototype administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 Reference (Part A)<br>Multiple doses of LY3502970 reference administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 Prototype (Part B)<br>Multiple doses of LY3502970 prototype administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: LY3502970 Reference (Part B)<br>Multiple doses of LY3502970 reference administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Active Comparator: Esomeprazole (Part B)<br>Multiple doses of Esomeprazole (Proton Pump Inhibitor) administered orally. | Drug: Esomeprazole<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 24 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | PK: AUC of LY3502970 | Predose up to 24 hours postdose | 
| PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 | PK: Tmax of LY3502970 | Predose up to 24 hours postdose |