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LY3537982 + Itraconazole (Part 1) 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 up to 72 hours postdose on day 13

Awards & highlights

Study Summary

This trial tests how two drugs and a new drug affect healthy adults, measuring safety and drug levels. Participants will stay in the research center for 11-15 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose on day 1 up to 72 hours postdose on day 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose on day 1 up to 72 hours postdose on day 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 up to 72 hours postdose on day 13 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: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole

PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine

PK: AUClast of LY3537982 administered with or without carbamazepine

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: LY3537982 + Itraconazole (Part 1)Experimental Treatment2 Interventions

LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.

Group II: LY3537982 + Carbamazepine (Part 2)Experimental Treatment2 Interventions

LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3537982

2023

Completed Phase 1

~100

Itraconazole

2017

Completed Phase 2

~780

Carbamazepine

2016

Completed Phase 4

~2690

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

2,618 Previous Clinical Trials

3,201,530 Total Patients Enrolled

Loxo Oncology, Inc.Industry Sponsor

66 Previous Clinical Trials

9,839 Total Patients Enrolled

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

3 Previous Clinical Trials

106 Total Patients Enrolled

Frequently Asked Questions

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

Are there any octogenarians participating in the experiment?

"To qualify for this clinical trial, applicants must be between 18 and 55 years old. Conversely, there are 58 separate trials available to those under the age of 18 and 370 specifically designed for individuals over 65."

Answered by AI

What are the safety protocols for administering LY3537982 in combination with Itraconazole to patients?

"As this is only a Phase 1 trial, the risk/benefit profile of LY3537982 + Itraconazole (Part 1) has been estimated at just one on our scale from 1 to 3. Data supporting safety and efficacy is still limited for this drug combination."

Answered by AI

Is the recruitment of participants still underway for this research?

"Affirmative. The clinicaltrials.gov website reveals that this research is actively recruiting members; the protocol for participation was established on May 8th 2023 and has since been revised once, also on May 8th 2023. Thus far, 30 volunteers have been sourced from a single medical facility."

Answered by AI

Is it feasible for me to join this research endeavor?

"To be eligible to partake in this medical trial, candidates should have no existing ailments and must fall between the ages of 18-55. Approximately 30 individuals will be accepted into the study."

Answered by AI

How many participants are included in this medical experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical investigation is currently accepting applicants and was published during May 8th of 2023 with the same date for its most recent amendement. 30 individuals need to be recruited from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

2023. "A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05860933.