A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

NCT ID: NCT06181084

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2022-04-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1: Tablet versus Capsule

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.

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Administered orally.

Group 2: Food Effect Comparison Group

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.

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Administered orally.

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

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.

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Administered orally.

Esomeprazole

Intervention Type: DRUG

Administered orally.

Group 4: pH Effect Fed Group

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.

Group Type: EXPERIMENTAL

LY3410738

Intervention Type: DRUG

Administered orally.

Esomeprazole

Intervention Type: DRUG

Administered orally.

Interventions

LY3410738

Administered orally.

Intervention Type: DRUG

Esomeprazole

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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.
• Have history of a major surgical procedure within 30 days prior to Screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingying Guo-Avrutin

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

Labcorp Clinical Research

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

I9Y-OX-JDHE

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-IDH-21004

Identifier Type: -

Identifier Source: org_study_id