A Study of LY3410738 in Healthy Adult Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3410738

Study type: Interventional

Funder types: Industry

Identifiers

NCT06181045

LOXO-IDH-20003

I9Y-OX-JDHD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 7 patient groups, including a placebo group

Cohort 1 (Treatment A): LY3410738

Experimental group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.

Treatment:

Drug: Placebo

Drug: LY3410738

Cohort 2 (Treatment B): LY3410738

Placebo Comparator group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.

Treatment:

Drug: Placebo

Drug: LY3410738

Cohort 3 (Treatment C): LY3410738

Experimental group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

Treatment:

Drug: Placebo

Drug: LY3410738

Cohort 4 (Treatment D): LY3410738

Experimental group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

Treatment:

Drug: Placebo

Drug: LY3410738

Cohort 5 (Treatment E): LY3410738

Experimental group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

Treatment:

Drug: Placebo

Drug: LY3410738

Cohort 6 (Treatment F): LY3410738

Experimental group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

Treatment:

Drug: Placebo

Drug: LY3410738

Cohort 7 (Treatment G): LY3410738

Experimental group

Description:

Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

Treatment:

Drug: Placebo

Drug: LY3410738