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

NCT ID: NCT06153355

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-05-22

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3839840 (Part A)

Single ascending dose of LY3839840 administered orally.

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

LY3839840 (Part B) Cohort 1-3

Multiple ascending dose of LY3839840 administered orally.

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

LY3839840 (Part B) Cohort 4

Multiple ascending dose of LY3839840 administered orally.

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

LY3839840 (Part B) Optional Cohort 5

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

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

LY3839840 (Part C)

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

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

LY3839840 (Part D)

Multiple ascending dose of LY3839840 administered orally in Japanese participants.

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

Placebo (Parts A-D)

Placebo administered orally.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Midazolam (Part E)

Midazolam substrate alone or with LY3839840 administered orally

Group Type: EXPERIMENTAL

LY3839840

Intervention Type: DRUG

Administered orally.

Midazolam

Intervention Type: DRUG

Administered orally

Interventions

LY3839840

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Midazolam

Administered orally

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

CenExel ACT

Anaheim, California, United States

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

J4U-MC-KTAA

Identifier Type: OTHER

Identifier Source: secondary_id

18798

Identifier Type: -

Identifier Source: org_study_id