A Safety Study of LY3526318 in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-29

Study Completion Date

2021-04-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3526318 (Part A)

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

Group Type EXPERIMENTAL

LY3526318

Intervention Type DRUG

Administered orally.

LY3526318 (Part B)

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

Group Type EXPERIMENTAL

LY3526318

Intervention Type DRUG

Administered orally.

Placebo (Part A)

Placebo administered orally under fasted or fed condition.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Placebo (Part B)

Placebo administered orally under fasted or fed condition.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY3526318

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes