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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on day 1 upto 96 hours postdose of each treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 upto 96 hours postdose of each treatment period
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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,672 Previous Clinical Trials
3,463,721 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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: LOXO-783 alone
- Group 2: LOXO-783 + Cholestyramine 1 hour post dose
- Group 3: LOXO-783 + Cholestyramine 4 hours post dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05894928 — Phase 1
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