Skip to main content
OpenTrials
Completed

NCT Number: NCT04682119

A Safety Study of LY3526318 in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, 9728, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3526318

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

  1. Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318

    Time frame: 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

  2. Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

    Time frame: 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

  3. 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

    Time frame: 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

  4. Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

    Time frame: 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 outcomes

  1. Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  2. Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  3. Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)

    Time frame: 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)

  4. Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)

    Time frame: 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-∞)

  5. Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.