A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants

Eli Lilly and Company42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LOXO-783DRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783

PK: Cmax of LOXO-783

Time frame: Predose on Day 1 up to 96 hours postdose

PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783

PK: AUC \[0-∞\] of LOXO-783

Time frame: Predose on Day 1 up to 96 hours postdose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.