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

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 Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: LOXO-783

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Patient Advocacy; Phone Number: 08555696305; Email: clinicaltrials@loxooncology.com

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Recruiting
      • Fortrea Clinical Research Unit
      • Contact: Phone Number: 386-366-6400
      • Principal Investigator: Kathleen Doisy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOXO-783 (Fasted State); LOXO-783 administered orally to participants who are in fasted state	Drug: LOXO-783; Administered orally.; Other Names: LY3849524
Experimental: LOXO-783 (Fed State - Low Fat Meal); LOXO-783 administered orally to participants who are on low fat meal	Drug: LOXO-783; Administered orally.; Other Names: LY3849524
Experimental: LOXO-783 (Fed State - High Fat Meal); LOXO-783 administered orally to participants who are on high fat meal	Drug: LOXO-783; Administered orally.; Other Names: LY3849524

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783	PK: Cmax of LOXO-783	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	Predose on Day 1 up to 96 hours postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: Yingying Guo-Avrutin, MD, PhD, Loxo Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LOXO-PIK-22004; J4C-OX-JZUC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No