A Study of LY3410738 in Healthy Adult Participants

Eli Lilly and Company42 enrolled

Overview

The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3410738DRUG

Administered orally.

PlaceboDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive * Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator * Female participants of non-childbearing potential and male participants who follow standard contraceptive methods * Must comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call Exclusion Criteria: * History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor * Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening. * Positive polymerase chain reaction (PCR) test for COVID-19 at Screening * Known ongoing alcohol and/or drug abuse within 2 years prior to Screening * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) * Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1

Locations (2)

Covance Clinical Research Unit

Daytona Beach, Florida, United States

Covance Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time frame: Baseline through 53 days

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738

PK: AUC0-24 of LY3410738

Time frame: Pre-dose up to 24 hours post-dose

PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738

PK: AUC0-t of LY3410738

Time frame: Pre-dose up to 48 hours post-dose

PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738

PK: Cmax of LY3410738

Time frame: Pre-dose up to 48 hours post-dose

PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738

PK: Tmax of LY3410738

Time frame: Pre-dose up to 48 hours post-dose

Data from ClinicalTrials.gov

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