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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 up to 96 hours postdose
Awards & highlights
Study Summary
This trial studies the safety & tolerability of a drug & how it's handled by the body. Participation could last up to 63 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on day 1 up to 96 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 up to 96 hours postdose
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-∞]) of LOXO-783
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
Trial Design
3Treatment groups
Experimental Treatment
Group I: LOXO-783 (Fed State - Low Fat Meal)Experimental Treatment1 Intervention
LOXO-783 administered orally to participants who are on low fat meal
Group II: LOXO-783 (Fed State - High Fat Meal)Experimental Treatment1 Intervention
LOXO-783 administered orally to participants who are on high fat meal
Group III: LOXO-783 (Fasted State)Experimental Treatment1 Intervention
LOXO-783 administered orally to participants who are in fasted state
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOXO-783
2023
Completed Phase 1
~30
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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
2,624 Previous Clinical Trials
3,216,882 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
67 Previous Clinical Trials
10,147 Total Patients Enrolled
Yingying Guo-Avrutin, MD, PhDStudy DirectorLoxo Oncology, Inc.
3 Previous Clinical Trials
94 Total Patients Enrolled
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