A Study of LY3410738 in Healthy Adult Participants

NCT06181045 | Completed Phase 1 FDA Drug

• 2 other identifiers: LOXO-IDH-20003I9Y-OX-JDHD
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline through 53 days

Secondary Outcomes (4)

• 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: 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: Maximum Observed Plasma Concentration (Cmax) of LY3410738

  Pre-dose up to 48 hours post-dose

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

  Pre-dose up to 48 hours post-dose

Study Arms (7)

Cohort 1 (Treatment A): LY3410738

EXPERIMENTAL

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

Drug: LY3410738; Drug: Placebo

Cohort 2 (Treatment B): LY3410738

PLACEBO COMPARATOR

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

Drug: LY3410738; Drug: Placebo

Cohort 3 (Treatment C): LY3410738

EXPERIMENTAL

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

Drug: LY3410738; Drug: Placebo

Cohort 4 (Treatment D): LY3410738

EXPERIMENTAL

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

Drug: LY3410738; Drug: Placebo

Cohort 5 (Treatment E): LY3410738

EXPERIMENTAL

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

Drug: LY3410738; Drug: Placebo

Cohort 6 (Treatment F): LY3410738

EXPERIMENTAL

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

Drug: LY3410738; Drug: Placebo

Cohort 7 (Treatment G): LY3410738

EXPERIMENTAL

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

Drug: LY3410738; Drug: Placebo

Interventions

LY3410738 DRUG

Administered orally.

Cohort 1 (Treatment A): LY3410738; Cohort 2 (Treatment B): LY3410738; Cohort 3 (Treatment C): LY3410738; Cohort 4 (Treatment D): LY3410738; Cohort 5 (Treatment E): LY3410738; Cohort 6 (Treatment F): LY3410738; Cohort 7 (Treatment G): LY3410738

Placebo DRUG

Administered orally.

Cohort 1 (Treatment A): LY3410738; Cohort 2 (Treatment B): LY3410738; Cohort 3 (Treatment C): LY3410738; Cohort 4 (Treatment D): LY3410738; Cohort 5 (Treatment E): LY3410738; Cohort 6 (Treatment F): LY3410738; Cohort 7 (Treatment G): LY3410738

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Loxo Oncology, Inc.: collaborator

Study Sites (2)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Yingying Guo-Avrutin

  Loxo Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: February 24, 2021
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)