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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LOXO-783
* Drug: Cholestyramine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOXO-783 alone<br>Single dose of LOXO-783 administered orally. | Drug: LOXO-783<br>* Administered orally.<br>* Other names: LY3849524;|
| Experimental: LOXO-783 + Cholestyramine 1 hour post dose<br>Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour. | Drug: LOXO-783<br>* Administered orally.<br>* Other names: LY3849524;Drug: Cholestyramine<br>* Administered orally.<br>|
| Experimental: LOXO-783 + Cholestyramine 4 hours post dose<br>Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours. | Drug: LOXO-783<br>* Administered orally.<br>* Other names: LY3849524;Drug: Cholestyramine<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholestyramine, LOXO-783