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NCT05894928 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05894928
Other study ID # LOXO-PIK-23009
Secondary ID J4C-OX-JZUD
Status Completed
Phase Phase 1
First received
Last updated
Start date June 7, 2023
Est. completion date July 9, 2023

Study information
Verified date September 2023
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 9, 2023
Est. primary completion date July 9, 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.
• Cholestyramine
Administered orally.

Locations
Country Name City State
United States Labcorp Clinical Research Unit Dallas Texas

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 upto 96 hours postdose of each treatment period
Primary 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 Predose on Day 1 upto 96 hours postdose of each treatment period
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