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LOXO-783 in Healthy Participants

Phase 1

Recruiting

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 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 up to 96 hours postdose 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-∞]) 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

Do I qualify?Apply below to find out

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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

2,613 Previous Clinical Trials

3,200,887 Total Patients Enrolled

Loxo Oncology, Inc.Industry Sponsor

66 Previous Clinical Trials

9,827 Total Patients Enrolled

Yingying Guo-Avrutin, MD, PhDStudy DirectorLoxo Oncology, Inc.

3 Previous Clinical Trials

94 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment in this clinical trial ongoing at present?

"As displayed on clinicaltrials.gov, this medical study is currently recruiting participants and opened for enrollment on August 2nd 2023 with its latest update occurring on September 1st 2023."

Answered by AI

Does this research endeavor include individuals aged seventy-five or older?

"Applicants between the ages of 18 to 55 are eligible for this clinical trial; there are 63 trials catered towards minors and 404 studies intended for those aged 65 or over."

Answered by AI

Is LOXO-783 (Fasted State) a risk-free medication for human usage?

"The safety of LOXO-783 (Fasted State) has been given a score of 1 as this is an initial phase trial. Consequently, there is limited data regarding efficacy and potential risks associated with the medication."

Answered by AI

Who qualifies to take part in this trial?

"Those wishing to be included in this research should have no preexisting health conditions and must fall between 18-55 years of age. Currently, the study is seeking approximately 42 volunteers."

Answered by AI

What is the participant recruitment number for this research endeavor?

"Yes, the clinicaltrials.gov website states that this medical experiment is presently seeking participants after being originally posted on August 2nd 2023 and updated most recently on September 1st 2023. 42 patients are required from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028425.