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

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 upto 96 hours postdose of each treatment period
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, LOXO-783, alone and with another drug, cholestyramine, in healthy people. Researchers want to see how much of LOXO-783 stays in the blood and how quickly it leaves the body. They also want to check if cholestyramine changes these effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 upto 96 hours postdose of each treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 upto 96 hours postdose of each treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: LOXO-783 aloneExperimental Treatment1 Intervention
Single dose of LOXO-783 administered orally.
Group II: LOXO-783 + Cholestyramine 4 hours post doseExperimental Treatment2 Interventions
Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours.
Group III: LOXO-783 + Cholestyramine 1 hour post doseExperimental Treatment2 Interventions
Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOXO-783
2023
Completed Phase 1
~80
Cholestyramine
2018
Completed Phase 4
~340

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,732 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
11,039 Total Patients Enrolled
Yingying Guo-Avrutin, MD; PhDStudy DirectorLoxo Oncology, Inc.

Media Library

LOXO-783 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05894928 — Phase 1
Healthy Subjects Research Study Groups: LOXO-783 alone, LOXO-783 + Cholestyramine 1 hour post dose, LOXO-783 + Cholestyramine 4 hours post dose
Healthy Subjects Clinical Trial 2023: LOXO-783 Highlights & Side Effects. Trial Name: NCT05894928 — Phase 1
LOXO-783 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05894928 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05894928 — Phase 1
~8 spots leftby Dec 2025
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