Skip to main content
OpenTrials
Completed

NCT Number: NCT05894928

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

The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last up to 63 days including screening period.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOXO-783

Drug

Administered orally.

Other names: LY3849524

Cholestyramine

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783

    Time frame: Predose on Day 1 upto 96 hours postdose of each treatment period

    PK: Cmax of LOXO-783

  2. PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783

    Time frame: Predose on Day 1 upto 96 hours postdose of each treatment period

    PK: AUC(0-inf) of LOXO-783

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

A Phase 1 Study to Investigate the Effect of Cholestyramine on the Pharmacokinetics of LOXO-783 in Healthy Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.