A Safety Study of LY3526318 in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: LY3526318
Drug: Placebo

Registration Number: NCT04682119

Lead Sponsor: Eli Lilly and Company

Brief Summary: The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

Inclusion Criteria

Are overtly healthy males or females, as determined through medical history and physical examination
Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
Have clinical laboratory test results within normal reference range

Exclusion Criteria

Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of clinically significant multiple or severe drug allergies
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
Have an abnormal blood pressure
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
Are unwilling to stop herbal supplements, over the counter or prescription medicines
Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants with a history of drug abuse

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3526318 (Part A)	LY3526318	250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition.
Placebo (Part A)	Placebo	Placebo administered orally under fasted or fed condition.
LY3526318 (Part B)	LY3526318	250 mg LY3526318 administered orally as multiple doses under fasted or fed condition.
Placebo (Part B)	Placebo	Placebo administered orally under fasted or fed condition.

Primary Outcome Measures

Name	Time	Method
Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318	Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose	Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318	Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose	Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318	Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose	Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318	Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose	Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

Secondary Outcome Measures

Name	Time	Method
Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Single oral dose to up to 11 days of follow-up	A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 14 days following first dose	A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)	Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose	Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax)
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)	Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose	Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞)
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)	Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose	Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)