A Study of LY3526318 in Healthy Participants

Phase 1

Terminated

Brief Summary: The main purpose of this study is to learn more about the safety and side effects of LY3526318 when given by mouth 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 28 days and Part B will last up to 51 days, including screening and follow-up.

Recruitment & Eligibility

Inclusion Criteria

Part A Cohorts:

- Healthy male participants (including self-reported surgically sterile males) must agree to the following:

When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration
Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug

All Part A and Part B Cohorts:

Exclusion Criteria

Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
In the opinion of the investigator are considered to be a danger to themselves
Have an abnormality in the 12-lead electrocardiogram (ECG)
Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions
Have donated blood of more than 500 milliliter (mL) within the previous month
Are unwilling to stop alcohol and caffeinated beverage consumption and smoking/use of tobacco while resident in the CRU
Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits
Have an abnormal blood pressure
Participants with a history of drug abuse
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 comply with the required dietary restrictions

Arm && Interventions

Group	Intervention	Description
LY3526318 - Part A	LY3526318	Single-ascending dose (SAD) 10 milligram (mg), 30 mg, 50 mg, or 300 mg LY3526318 administered orally. 100 mg LY3526318 administered orally without a meal in period 1 and 30 mg LY3526318 administered orally with a meal in period 2. 200 mg LY3526318 administered orally without a meal in period 1 and 200 mg LY3526318 administered orally with a meal in period 2. 100 mg LY3526318 Fed: Period 1: 100 mg LY3526318 administered orally 30 minutes (min) after breakfast (Fed (-30 min.)). Period 2: 100 mg LY3526318 orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed (+60 min.)). Placebo Fed: Period 1: Placebo administered orally 30 minutes after breakfast (Fed (-30 min.)). Period 2: Placebo administered orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: Placebo administered orally 60 minutes before breakfast (Fed (+60 min.)).
Placebo - Part A	Placebo	Participants received placebo administered orally once.
LY3526318 - Part B	LY3526318	Multiple-ascending dose (MAD): 30 mg LY3526318 once daily (QD): Participants received 30 mg LY3526318 QD administered orally for 14 days. MAD: 60 mg LY3526318 QD: Participants received 60 mg LY3526318 QD administered orally for 14 days. MAD: 100 mg LY352631 QD: Participants received 100 mg LY3526318 QD administered orally for 14 days.
Placebo - Part B	Placebo	Participants received placebo QD orally for 14 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline Up To 32 Days	An SAE is any AE from this study that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e. immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318	SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC\[0-∞\]) of LY3526318
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3526318	MAD: Day 1: Predose,1, 2, 4, 6, 8 and 12 hours post dose	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC\[0-24\]) of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318	MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose	PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
PK: Time to Maximum Concentration (Tmax) of LY3526318	MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose	PK: Time to Maximum Concentration (Tmax) of LY3526318