A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

NCT06181084 | Completed Phase 1 FDA Drug

• 2 other identifiers: LOXO-IDH-21004I9Y-OX-JDHE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of study is to compare different formulations of LY3410738 under fasting condition by looking 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. The study will also access the effect of standard low-fat meal and esomeprazole (Proton Pump Inhibitor) on LY3410738. Safety and tolerability of LY3410738 will also be evaluated. For each participant, the total duration of the study will be 56 days for Groups 1 and 2 and up to 61 days for Groups 3 and 4, including screening.

Conditions

Healthy

Keywords

Formulation, food effect, proton pump inhibitor

Outcome Measures

Primary Outcomes (12)

• Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules

  PK: AUC0-tlast of LY3410738 Tablets Versus Capsules

  Predose up to 48 hours postdose

• PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules

  PK: AUC0-∞ of LY3410738 Tablets Versus Capsules

  Predose up to 48 hours postdose

• PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules

  PK: Cmax of LY3410738 Tablets Versus Capsules

  Predose up to 48 hours postdose

• PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal

  PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal

  Predose up to 48 hours postdose

• PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal

  PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal

  Predose up to 48 hours postdose

• PK: Cmax of LY3410738 After Standard Low-Fat Meal

  PK: Cmax of LY3410738 After Standard Low-Fat Meal

  Predose up to 48 hours postdose

• PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State

  PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State

  Predose up to 48 hours postdose

• PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State

  PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State

  Predose up to 48 hours postdose

• PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State

  PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State

  Predose up to 48 hours postdose

• PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State

  PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State

  Predose up to 48 hours postdose

• PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State

  PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State

  Predose up to 48 hours postdose

• PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State

  PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State

  Predose up to 48 hours postdose

Study Arms (4)

Group 1: Tablet versus Capsule

EXPERIMENTAL

Treatment A: LY3410738 capsule on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment B: LY3410738 tablet on Day 4 as a single oral dose in the morning 10 hours prior to and 4 hours after dosing.

Drug: LY3410738

Group 2: Food Effect Comparison Group

EXPERIMENTAL

Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment C: LY3410738 table on Day 4 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal.

Drug: LY3410738

Group 3: Potential of Hydrogen (pH) Effect Fasted Group

EXPERIMENTAL

Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment D: Esomeprazole single oral dose once daily (QD) in the morning on Days 4 through 8 in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole a single oral dose followed by LY3410738 tablet as a single oral dose in the morning, following a fast of at least 10 hours prior to and 4 hours after esomeprazole and LY3410738 coadministration.

Drug: LY3410738; Drug: Esomeprazole

Group 4: pH Effect Fed Group

EXPERIMENTAL

Treatment C: LY3410738 table on Day 1 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Treatment E: Esomeprazole as a single oral dose QD in the morning on Days 4 through 8, in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole as a single oral dose followed by a LY3410738 tablet in the morning in fed state standard low-fat meal.

Drug: LY3410738; Drug: Esomeprazole

Interventions

LY3410738 DRUG

Administered orally.

Group 1: Tablet versus Capsule; Group 2: Food Effect Comparison Group; Group 3: Potential of Hydrogen (pH) Effect Fasted Group; Group 4: pH Effect Fed Group

Esomeprazole DRUG

Administered orally.

Group 3: Potential of Hydrogen (pH) Effect Fasted Group; Group 4: pH Effect Fed Group

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/m\^2), 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 have 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.
• Have history of a major surgical procedure within 30 days prior to Screening.

Sponsors & Collaborators

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

Study Sites (1)

Labcorp Clinical Research

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yingying Guo-Avrutin

  Loxo Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: October 11, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)