A Safety Study of LY3526318 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3526318

Study type: Interventional

Funder types: Industry

Identifiers

NCT04682119

2020-004290-46 (EudraCT Number)

17807

J2D-MC-CVAC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

16 participants in 4 patient groups, including a placebo group

LY3526318 (Part A)

Experimental group

Description:

250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition.

Treatment:

Drug: LY3526318

LY3526318 (Part B)

Experimental group

Description:

250 mg LY3526318 administered orally as multiple doses under fasted or fed condition.

Treatment:

Drug: LY3526318

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered orally under fasted or fed condition.

Treatment:

Drug: Placebo

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered orally under fasted or fed condition.

Treatment:

Drug: Placebo