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

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Study Start: 2020-12-29
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-21
• Status Verified: 2021-06-01
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10

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 B)	LY3526318	LY3526318 administered orally as multiple doses.
Placebo (Part A)	Placebo	Placebo administered orally.
LY3526318 (Part A)	LY3526318	LY3526318 administered orally as single ascending doses.
Placebo (Part B)	Placebo	Placebo administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318	Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8	PK: AUC of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318	Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8	PK: Cmax of LY3526318

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands