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NCT06028425 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06028425
Other study ID # LOXO-PIK-22004
Secondary ID J4C-OX-JZUC
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 2, 2023
Est. completion date December 2023

Study information
Verified date September 2023
Source Eli Lilly and Company
Contact Patient Advocacy
Phone 08555696305
Email clinicaltrials@loxooncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 42
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• LOXO-783
Administered orally.

Locations
Country Name City State
United States Fortrea Clinical Research Unit Daytona Beach Florida

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783 PK: Cmax of LOXO-783 Predose on Day 1 up to 96 hours postdose
Primary PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-8]) of LOXO-783 PK: AUC [0-8] of LOXO-783 Predose on Day 1 up to 96 hours postdose
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