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LOXO-783 alone for Healthy Subjects

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

Study Summary

This trial will measure how safe and effective a drug is in healthy participants by testing blood levels and assessing how the body handles it. Participation could last up to 63 days.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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
~30
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
2,618 Previous Clinical Trials
3,201,539 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
9,848 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I possess the requisite qualifications to participate in this medical study?

"Eligibility to join this clinical trial dictates that subjects must be in a healthy state of being and between 18-55 years old. The team is seeking roughly 21 volunteers for the experiment."

Answered by AI

Does this research protocol accept participants aged 25 and above?

"This research is recruiting patients of legal age or older, who are not yet 55 years old."

Answered by AI

Has LOXO-783 been granted regulatory clearance by the FDA as a single agent?

"Due to the preliminary nature of this trial, our team at Power assigned LOXO-783 a score of 1 in regards to its overall safety. This is because Phase 1 trials provide limited evidence related to both efficacy and security."

Answered by AI

Is this study recruiting participants at the moment?

"Correct. Records available on clinicaltrials.gov demonstrate that this experiment is open to applications, having been initially posted on June 7th 2023 and updated as recently as June 6th 2023. A total of 21 individuals are needed for the trial from a single site."

Answered by AI

What is the enrollment capacity of this medical trial?

"Affirmative. According to clinicaltrials.gov, this healthcare research venture is currently recruiting subjects; the trial was first posted on June 7th 2023 and finally updated on 6/6/2023. A total of 21 participants are needed across one location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Mississippi
What site did they apply to?
Labcorp Clinical Research Unit
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’m healthy so it’s really kind of up to me. And other’s like me to test the toxicity of new drugs. Certainly can’t recommend doing so on sick people, right?
PatientReceived 2+ prior treatments
~11 spots leftby Apr 2025