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

NCT06153355 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18798J4U-MC-KTAA
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

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

  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

  Baseline up to Week 8

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840

  Predose on day 1 up to 14 days post dose

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

  Predose on day 1 up to 14 days post dose

• PK: AUC of Midazolam

  Predose on day 1 up to 19 days post-dose

• PK: Cmax of Midazolam

  Predose on day 1 up to 19 days post-dose

Study Arms (8)

LY3839840 (Part A)

EXPERIMENTAL

Single ascending dose of LY3839840 administered orally.

Drug: LY3839840

LY3839840 (Part B) Cohort 1-3

EXPERIMENTAL

Multiple ascending dose of LY3839840 administered orally.

Drug: LY3839840

LY3839840 (Part B) Cohort 4

EXPERIMENTAL

Multiple ascending dose of LY3839840 administered orally.

Drug: LY3839840

LY3839840 (Part B) Optional Cohort 5

EXPERIMENTAL

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

Drug: LY3839840

LY3839840 (Part C)

EXPERIMENTAL

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

Drug: LY3839840

LY3839840 (Part D)

EXPERIMENTAL

Multiple ascending dose of LY3839840 administered orally in Japanese participants.

Drug: LY3839840

Placebo (Parts A-D)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Midazolam (Part E)

EXPERIMENTAL

Midazolam substrate alone or with LY3839840 administered orally

Drug: LY3839840; Drug: Midazolam

Interventions

LY3839840 DRUG

Administered orally.

LY3839840 (Part A); LY3839840 (Part B) Cohort 1-3; LY3839840 (Part B) Cohort 4; LY3839840 (Part B) Optional Cohort 5; LY3839840 (Part C); LY3839840 (Part D); Midazolam (Part E)

Placebo DRUG

Administered orally.

Placebo (Parts A-D)

Midazolam DRUG

Administered orally

Midazolam (Part E)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

CenExel ACT

Anaheim, California, 92801, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part E is non-randomized and open-label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 4, 2023
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)