Testing LY3839840 in healthy participants

Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3839840 Following Oral Dosing in Healthy Participants

This study is testing a new drug called LY3839840 in healthy people to see if it's safe and how it works in the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 2 sites (Anaheim, California and 1 other locations)
• Trial ID: NCT06153355 on ClinicalTrials.gov

What this trial studies

This first-in-human study aims to evaluate the safety and pharmacokinetics of LY3839840 in healthy individuals. Participants will receive either a single or multiple doses of LY3839840 or a placebo across five different parts of the study. The study will last up to approximately 8 weeks, with specific cohorts for Chinese and Japanese participants to assess the drug's effects in these populations. Additionally, the study will include an evaluation of midazolam in conjunction with LY3839840.

Who should consider this trial

Good fit: Ideal candidates include healthy men and women, particularly those of Chinese or Japanese descent for specific parts of the study.

Not a fit: Patients with underlying health conditions or those not meeting the specific ethnic criteria for Parts C and D may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data for LY3839840, paving the way for its use in future therapeutic applications.

How similar studies have performed: Other first-in-human studies have shown success in establishing safety profiles for new drugs, making this approach a standard practice in drug development.

Eligibility criteria

Inclusion Criteria:

Healthy men and women. Women may only be included if they are of nonchildbearing potential

For Part C:

• Part C of the study includes Chinese participants only. To qualify, the participants must be considered as native Chinese, defined as all the participant's biological grandparents being of Chinese origin

For Part D:

* Part D of the study includes Japanese participants only. To qualify, the participants must be first-generation Japanese, defined as the participant's biological parents, and all the participant's biological grandparents, being of exclusive Japanese descent, and being born in Japan
* Participants who are healthy as determined through medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead (electrocardiogram ECG)
* Have a body mass index (BMI) of greater than or equal to 18 to less than or equal to 35 kilograms per square meter (kg/m²). For Parts C and D: BMI greater than or equal to 18 to less than or equal to 29 kilograms per square meter (kg/m²)
* Participants who have laboratory tests within the normal reference range for the population or CRU or have results with acceptable deviations that are judged by the investigator not to be clinically significant
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Have known allergies to LY3839840, related compounds, or any components of the formulation
* Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy
* Have a significant history of or current rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism, hyperaldosteronism), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data
* Have had any significant infections within 3 months prior to the screening visit, or develop any of these infections before the randomization visit.
* Have received ≥1 live vaccine within 28 days of screening, or intend to during the study, or ≤28 days after the study
* Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening, or intend to during the study, or ≤28 days after the study
* Had any malignancy within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma with no evidence of recurrence or metastatic disease within the past 3 years
* Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant
* Have used, or intend to use, prescription or nonprescription medication within 14 days prior to dosing (or 5 half-lives - whichever is longer)
* 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
* Have participated in a clinical study involving an investigational product within the last 30 days of the final drug administration (or 5 half-lives - whichever is longer)
* Show evidence of active or latent TB
* Are females who are lactating or have a positive pregnancy test at screening or Day -1
* Blood donation of ≥450 mL, or participation in a clinical study that required a blood volume of ≥400 mL since the last study visit within the past 120 days

Where this trial is running

Anaheim, California and 1 other locations

• CenExel ACT — Anaheim, California, United States (COMPLETED)
• Fortrea Clinical Research Unit — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Conditions: Healthy