A Study of LY3410738 in Healthy Adult Participants

A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3410738

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Unit
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (Treatment A): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.
Placebo Comparator: Cohort 2 (Treatment B): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.
Experimental: Cohort 3 (Treatment C): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.
Experimental: Cohort 4 (Treatment D): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.
Experimental: Cohort 5 (Treatment E): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.
Experimental: Cohort 6 (Treatment F): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.
Experimental: Cohort 7 (Treatment G): LY3410738; Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.	Drug: Placebo; Administered orally.; Drug: LY3410738; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Pre-dose up to 48 hours post-dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738	PK: Cmax of LY3410738	Pre-dose up to 48 hours post-dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738	PK: Tmax of LY3410738	Pre-dose up to 48 hours post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: Yingying Guo-Avrutin, Loxo Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): August 4, 2021

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LOXO-IDH-20003; I9Y-OX-JDHD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No