NCT06028425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

September 1, 2023

Last Update Submit

July 18, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

LOXO-783 (Fasted State)

EXPERIMENTAL

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

Drug: LOXO-783

LOXO-783 (Fed State - Low Fat Meal)

EXPERIMENTAL

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

Drug: LOXO-783

LOXO-783 (Fed State - High Fat Meal)

EXPERIMENTAL

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

Drug: LOXO-783

Interventions

LOXO-783DRUG

Administered orally.

Also known as: LY3849524
LOXO-783 (Fasted State)LOXO-783 (Fed State - High Fat Meal)LOXO-783 (Fed State - Low Fat Meal)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Females who are lactating or of childbearing potential
  • Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Study Officials

  • Yingying Guo-Avrutin, MD, PhD

    Loxo Oncology, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 8, 2023

Study Start

September 1, 2023

Primary Completion

December 23, 2023

Study Completion

December 23, 2023

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)