A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants
- Registration Number
- NCT06028425
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Exclusion Criteria
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LOXO-783 (Fasted State) LOXO-783 LOXO-783 administered orally to participants who are in fasted state LOXO-783 (Fed State - Low Fat Meal) LOXO-783 LOXO-783 administered orally to participants who are on low fat meal LOXO-783 (Fed State - High Fat Meal) LOXO-783 LOXO-783 administered orally to participants who are on high fat meal
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783 Predose on Day 1 up to 96 hours postdose PK: Cmax of LOXO-783
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783 Predose on Day 1 up to 96 hours postdose PK: AUC \[0-∞\] of LOXO-783
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States