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LY3410738 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 pre-dose up to 96 hours post-dose

Awards & highlights

Study Summary

This trial will study the effects of itraconazole and carbamazepine on the levels of LY3410738 in healthy participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose up to 96 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose up to 96 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 96 hours post-dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-inf

Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: AUC0-t

Assess the effect of multiple oral doses of carbamazepine on single oral dose PK of LY3410738 by collecting/evaluating serum at protocol-specified time points: Cmax

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2 Period 2 (LY3410738 + Carbamazepine)Experimental Treatment2 Interventions

Single dose of LY3410738 administered orally with multiple doses of carbamazepine orally.

Group II: Part 2 Period 1 (LY3410738 Alone)Experimental Treatment1 Intervention

Single dose of LY3410738 administered orally.

Group III: Part 1 Period 2 (LY3410738 + Itraconazole)Experimental Treatment2 Interventions

Single dose of LY3410738 administered orally with multiple doses of itraconazole orally.

Group IV: Part 1 Period 1 (LY3410738 Alone)Experimental Treatment1 Intervention

Single dose of LY3410738 administered orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itraconazole

2017

Completed Phase 2

~780

Carbamazepine

2016

Completed Phase 4

~2690

LY3410738

2021

Completed Phase 1

~110

Do I qualify?Apply below to find out

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

2,615 Previous Clinical Trials

3,201,031 Total Patients Enrolled

Loxo Oncology, Inc.Industry Sponsor

66 Previous Clinical Trials

9,842 Total Patients Enrolled

Yingying GuoStudy DirectorMedical Monitor

Frequently Asked Questions

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

Is it possible for me to join this clinical trial?

"This clinical trial is enrolling 27 patients with healthy subjects (hs) aged 18 and 55. Most importantly, candidates must meet the following criteria: Females of non-childbearing potential and males capable of fathering a child must use contraception, Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²)., Able to comply with all study procedures, including the 15-night stay for those participating in part 1 or 25-night stay for those participating in part 2 at the Clinical Research Unit and follow-up phone call., Participants will be in good health, based"

Answered by AI

Are there any positions available in this trial for new volunteers?

"That is accurate. The information on clinicaltrials.gov makes it clear that this study is currently looking for 27 patients from 1 site. The trial was originally posted on January 5th, 2022 and was last updated on October 6th, 2022."

Answered by AI

Are participants in this clinical trial restricted to those over 18 years old?

"Individuals that fall between 18 and 55 years old meet the age criteria to participate in this trial. There are 52 clinical trials currently underway for patients that are younger and 390 for patients that are older."

Answered by AI

How many total participants are included in this clinical trial?

"That is accurate. According to information available on clinicaltrials.gov, this study posted on 1/5/2022 is still recruiting patients. 27 individuals are needed for the research being conducted at 1 location."

Answered by AI

Has the FDA cleared LY3410738 for public use?

"LY3410738 is still in Phase 1 clinical trials, meaning that there is limited safety and efficacy data available. Our team at Power estimates that it is a 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants

2022. "Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05205447.