Clinical trial NCT06181084: A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Formulation, food effect, proton pump inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules
timeFrame: Predose up to 48 hours postdose
measure: PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules
timeFrame: Predose up to 48 hours postdose
measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of LY3410738 After Standard Low-Fat Meal
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State
timeFrame: Predose up to 48 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Labcorp Clinical Research
state: Florida
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin
role: STUDY_DIRECTOR
References: