A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

Healthy Clinical Trial

Official title:

A Pilot Study Comparing LY3410738 Capsule and Tablet Formulations and Effect of a Low-fat Meal and a Proton Pump Inhibitor on the Single-dose Pharmacokinetics of LY3410738 Tablets in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181084
• Other study ID #: LOXO-IDH-21004
• Secondary ID: I9Y-OX-JDHE
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: December 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3410738
Administered orally.
• Esomeprazole
Administered orally.

Locations

Country	Name	City	State
United States	Labcorp Clinical Research	Daytona Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-8) of LY3410738 Tablets Versus Capsules	PK: AUC0-8 of LY3410738 Tablets Versus Capsules	Predose up to 48 hours postdose
Primary	PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules	PK: Cmax of LY3410738 Tablets Versus Capsules	Predose up to 48 hours postdose
Primary	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
Primary	PK: AUC0-8 of LY3410738 After Standard Low-Fat Meal	PK: AUC0-8 of LY3410738 After Standard Low-Fat Meal	Predose up to 48 hours postdose
Primary	PK: Cmax of LY3410738 After Standard Low-Fat Meal	PK: Cmax of LY3410738 After Standard Low-Fat Meal	Predose up to 48 hours postdose
Primary	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
Primary	PK: AUC0-8 of LY3410738 after Esomeprazole oral dose in the Fasted State	PK: AUC0-8 of LY3410738 after Esomeprazole oral dose in the Fasted State	Predose up to 48 hours postdose
Primary	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
Primary	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
Primary	PK: AUC0-8 of LY3410738 after Esomeprazole oral dose in the Fed State	PK: AUC0-8 of LY3410738 after Esomeprazole oral dose in the Fed State	Predose up to 48 hours postdose
Primary	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