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

Eli Lilly and Company21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LOXO-783DRUG

Administered orally.

CholestyramineDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Labcorp Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

PK: Cmax of LOXO-783

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

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

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

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

Data from ClinicalTrials.gov

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