LY3839840 for Healthy Participants

Recruiting at 2 trial locations

Overseen By Nicholas Siebers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Prescription medications

Disqualifiers: Allergies, Infections, Cardiovascular, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7-8 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called LY3839840 to see if it is safe for humans. Participants will receive varying doses of the drug. Researchers will observe how the drug is processed in the body.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or nonprescription medications at least 14 days before the study starts, or longer if the medication takes more time to leave your body.

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults with good venous access for blood sampling. Specific parts require first-generation Chinese or Japanese descent, as defined by the participant's ancestry. Participants must have a BMI of >18 to ≤35 kg/m² (18-29 kg/m² for certain parts), normal vital signs and lab results, agree to contraceptive requirements, and not be pregnant.

Inclusion Criteria

For Part C: Participants must be first-generation Chinese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

I am a man who agrees to use contraception, or I am a woman who cannot become pregnant.

My BMI is between 18 and 35.

Exclusion Criteria

Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

I have taken, or plan to take, medication within the last 14 days or 5 half-lives, whichever is longer.

I have signs of active or latent tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single or multiple ascending doses of LY3839840 or placebo, and midazolam in Part E

7-8 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 weeks

Follow-up visits for safety assessments

What Are the Treatments Tested in This Trial?

Interventions

• LY3839840

Trial Overview The study tests LY3839840 against a placebo in healthy individuals to assess its safety at various doses and understand how it's processed by the body. It involves giving single and multiple doses of LY3839840 or a placebo.

How Is the Trial Designed?

Group I: Midazolam (Part E) Experimental Treatment 2 Interventions

Midazolam substrate alone or with LY3839840 administered orally

Group II: LY3839840 (Part D) Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally in Japanese participants.

Group III: LY3839840 (Part C) Experimental Treatment 1 Intervention

Single and multiple dose of LY3839840 administered orally in Chinese participants.

Group IV: LY3839840 (Part B) Optional Cohort 5 Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally pending data from Cohort 4

Group V: LY3839840 (Part B) Cohort 4 Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally.

Group VI: LY3839840 (Part B) Cohort 1-3 Experimental Treatment 1 Intervention

Multiple ascending dose of LY3839840 administered orally.

Group VII: LY3839840 (Part A) Experimental Treatment 1 Intervention

Single ascending dose of LY3839840 administered orally.

Group VIII: Placebo (Parts A-D) Placebo Group 1 Intervention

Placebo administered orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University