A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
LOXO-783 (Fasted State)
LOXO-783 administered orally to participants who are in fasted state
Intervention: LOXO-783 (Drug)
LOXO-783 (Fed State - Low Fat Meal)
LOXO-783 administered orally to participants who are on low fat meal
Intervention: LOXO-783 (Drug)
LOXO-783 (Fed State - High Fat Meal)
LOXO-783 administered orally to participants who are on high fat meal
Intervention: LOXO-783 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
Time Frame: 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
Time Frame: Predose on Day 1 up to 96 hours postdose
PK: AUC \[0-∞\] of LOXO-783
Secondary Outcomes
No secondary outcomes reported