A Study of LY3410738 in Healthy Adult Participants
- Registration Number
- NCT06181045
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 5 (Treatment E): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 5 (Treatment E): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 4 (Treatment D): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 7 (Treatment G): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 4 (Treatment D): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 1 (Treatment A): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. Cohort 2 (Treatment B): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. Cohort 3 (Treatment C): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 6 (Treatment F): LY3410738 Placebo Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 2 (Treatment B): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. Cohort 6 (Treatment F): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 7 (Treatment G): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. Cohort 1 (Treatment A): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. Cohort 3 (Treatment C): LY3410738 LY3410738 Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
- Primary Outcome Measures
Name Time Method 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 Baseline through 53 days A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738 Pre-dose up to 48 hours post-dose PK: AUC0-t of LY3410738
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Pre-dose up to 48 hours post-dose PK: Cmax of LY3410738
PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738 Pre-dose up to 48 hours post-dose PK: Tmax of LY3410738
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738 Pre-dose up to 24 hours post-dose PK: AUC0-24 of LY3410738
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States