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

A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06028425

Enrollment

Registered

2023-09-08

Start date

2023-09-01

Completion date

2023-12-23

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLOXO-783

Administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026