Healthy
Conditions
Keywords
Formulation, food effect, proton pump inhibitor
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.
Interventions
DRUGLY3410738
Administered orally.
DRUGEsomeprazole
Administered orally.
Sponsors
Loxo Oncology, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules | Predose up to 48 hours postdose | PK: AUC0-tlast of LY3410738 Tablets Versus Capsules |
| PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules | Predose up to 48 hours postdose | PK: AUC0-∞ of LY3410738 Tablets Versus Capsules |
| PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules | Predose up to 48 hours postdose | PK: Cmax of LY3410738 Tablets Versus Capsules |
| PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal | Predose up to 48 hours postdose | PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal |
| PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal | Predose up to 48 hours postdose | PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal |
| PK: Cmax of LY3410738 After Standard Low-Fat Meal | Predose up to 48 hours postdose | PK: Cmax of LY3410738 After Standard Low-Fat Meal |
| PK: AUC0-tlast 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 Fasted State |
| PK: AUC0-∞ 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: Cmax 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: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State | Predose up to 48 hours postdose | PK: AUC0-tlast 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: AUC0-∞ 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 | PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State |
Countries
United States
Outcome results
None listed