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Completed

NCT Number: NCT06181084

A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3410738

Drug

Administered orally.

Esomeprazole

Drug

Administered orally.

Primary outcomes

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

    Time frame: Predose up to 48 hours postdose

    PK: AUC0-tlast of LY3410738 Tablets Versus Capsules

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

    Time frame: Predose up to 48 hours postdose

    PK: AUC0-∞ of LY3410738 Tablets Versus Capsules

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

    Time frame: Predose up to 48 hours postdose

    PK: Cmax of LY3410738 Tablets Versus Capsules

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

    Time frame: Predose up to 48 hours postdose

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

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

    Time frame: Predose up to 48 hours postdose

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

  6. PK: Cmax of LY3410738 After Standard Low-Fat Meal

    Time frame: Predose up to 48 hours postdose

    PK: Cmax of LY3410738 After Standard Low-Fat Meal

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

    Time frame: Predose up to 48 hours postdose

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

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

    Time frame: Predose up to 48 hours postdose

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

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

    Time frame: Predose up to 48 hours postdose

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

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

    Time frame: Predose up to 48 hours postdose

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

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

    Time frame: Predose up to 48 hours postdose

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

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

    Time frame: Predose up to 48 hours postdose

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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