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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LOXO-783; Drug: Cholestyramine

• Registration Number: NCT05894928
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study Start: 2023-06-07
• Study First Posted: 2023-06-08
• Primary Completion: 2023-07-09
• Study Completion: 2023-07-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LOXO-783 alone	LOXO-783	Single dose of LOXO-783 administered orally.
LOXO-783 + Cholestyramine 1 hour post dose	Cholestyramine	Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour.
LOXO-783 + Cholestyramine 4 hours post dose	Cholestyramine	Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours.
LOXO-783 + Cholestyramine 1 hour post dose	LOXO-783	Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour.
LOXO-783 + Cholestyramine 4 hours post dose	LOXO-783	Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783	Predose on Day 1 upto 96 hours postdose of each treatment period	PK: AUC(0-inf) of LOXO-783
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783	Predose on Day 1 upto 96 hours postdose of each treatment period	PK: Cmax of LOXO-783

Trial Locations

Locations (1)

Labcorp Clinical Research Unit; 🇺🇸 Dallas, Texas, United States