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Completed

NCT Number: NCT06153355

A First-In-Human Study of LY3839840 in Healthy Participants

The main purpose of this first-in-human study to investigate the safety of LY3839840 in single and multiple doses, and how it's processed in the body when given in different amounts.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT, Anaheim, California, United States

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About this study

The study will be conducted in five parts (A, B, C, D, and E) and each enrolled participant will receive a single dose (Parts A and C) or multiple dose (Parts B, C and D) of either LY3839840 or placebo. Part E will study midazolam alone and with LY3839840. The study will last up to approximately 7 weeks for parts A, C (single dose cohort), 8 weeks for parts B, D and C (multiple dose cohort), and up to 3 weeks for Part E.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3839840

Drug

Administered orally.

Placebo

Drug

Administered orally.

midazolam

Drug

Administered orally

Primary outcomes

  1. Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

    Time frame: Baseline up to Week 8

    A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840

    Time frame: Predose on day 1 up to 14 days post dose

    PK:Cmax of LY3839840

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3839840

    Time frame: Predose on day 1 up to 14 days post dose

    PK: AUC of LY3839840

  3. PK: AUC of Midazolam

    Time frame: Predose on day 1 up to 19 days post-dose

    PK: AUC of Midazolam

  4. PK: Cmax of Midazolam

    Time frame: Predose on day 1 up to 19 days post-dose

    PK: Cmax of Midazolam

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2023
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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