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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LOXO-783

Study type: Interventional

Funder types: Industry

Identifiers

NCT06028425

LOXO-PIK-22004

J4C-OX-JZUC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

LOXO-783 (Fasted State)

Experimental group

Description:

LOXO-783 administered orally to participants who are in fasted state

Treatment:

Drug: LOXO-783

LOXO-783 (Fed State - Low Fat Meal)

Experimental group

Description:

LOXO-783 administered orally to participants who are on low fat meal

Treatment:

Drug: LOXO-783

LOXO-783 (Fed State - High Fat Meal)

Experimental group

Description:

LOXO-783 administered orally to participants who are on high fat meal

Treatment:

Drug: LOXO-783