HealthyPhase 1NCT06153355
A First-In-Human Study of LY3839840 in Healthy Participants
A Phase 1 study testing LY3839840 and Midazolam in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3839840 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2023to 22 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel ACT
Anaheim, California, 92801
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3839840 Following Oral Dosing 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3839840Drug
Administered orally.
PlaceboDrug
Administered orally.
MidazolamDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3839840 (Part A) | Experimental | Single ascending dose of LY3839840 administered orally. Receives: Drug: LY3839840 |
| LY3839840 (Part B) Cohort 1-3 | Experimental | Multiple ascending dose of LY3839840 administered orally. Receives: Drug: LY3839840 |
| LY3839840 (Part B) Cohort 4 | Experimental | Multiple ascending dose of LY3839840 administered orally. Receives: Drug: LY3839840 |
| LY3839840 (Part B) Optional Cohort 5 | Experimental | Multiple ascending dose of LY3839840 administered orally pending data from Cohort 4 Receives: Drug: LY3839840 |
| LY3839840 (Part C) | Experimental | Single and multiple dose of LY3839840 administered orally in Chinese participants. Receives: Drug: LY3839840 |
| LY3839840 (Part D) | Experimental | Multiple ascending dose of LY3839840 administered orally in Japanese participants. Receives: Drug: LY3839840 |
| Placebo (Parts A-D) | Placebo comparator | Placebo administered orally. Receives: Drug: Placebo |
| Midazolam (Part E) | Experimental | Midazolam substrate alone or with LY3839840 administered orally Receives: Drug: LY3839840; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline up to Week 8
Secondary outcomes (4)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840
PK:Cmax of LY3839840
Measured: Predose on day 1 up to 14 days post dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3839840
PK: AUC of LY3839840
Measured: Predose on day 1 up to 14 days post dose
PK: AUC of Midazolam
PK: AUC of Midazolam
Measured: Predose on day 1 up to 19 days post-dose
PK: Cmax of Midazolam
PK: Cmax of Midazolam
Measured: Predose on day 1 up to 19 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start4 Dec 2023
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153355
- Sponsor's protocol ID
- 18798
- Other IDs
- J4U-MC-KTAA
- Status last verified
- Jun 2025
- First submitted
- 22 Nov 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3839840 Following Oral Dosing in Healthy Participants
- ClinicalTrials.gov ID
- NCT06153355
- Acronym / sponsor ID
- 18798
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| LY3839840 (Part A) | Experimental | Drug: LY3839840Single ascending dose of LY3839840 administered orally. |
| LY3839840 (Part B) Cohort 1-3 | Experimental | Drug: LY3839840Multiple ascending dose of LY3839840 administered orally. |
| LY3839840 (Part B) Cohort 4 | Experimental | Drug: LY3839840Multiple ascending dose of LY3839840 administered orally. |
| LY3839840 (Part B) Optional Cohort 5 | Experimental | Drug: LY3839840Multiple ascending dose of LY3839840 administered orally pending data from Cohort 4 |
| LY3839840 (Part C) | Experimental | Drug: LY3839840Single and multiple dose of LY3839840 administered orally in Chinese participants. |
| LY3839840 (Part D) | Experimental | Drug: LY3839840Multiple ascending dose of LY3839840 administered orally in Japanese participants. |
| Placebo (Parts A-D) | Placebo comparator | Drug: PlaceboPlacebo administered orally. |
| Midazolam (Part E) | Experimental | Drug: LY3839840, Drug: MidazolamMidazolam substrate alone or with LY3839840 administered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy men and women. Women may only be included if they are of nonchildbearing potential
- 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
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3839840Administered orally. | Drug | 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) |
| PlaceboAdministered orally. | Drug | Placebo (Parts A-D) |
| MidazolamAdministered orally | Drug | Midazolam (Part E) |
Primary outcome
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
4 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840
Time frame: Predose on day 1 up to 14 days post dose
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 Midazolam
Time frame: Predose on day 1 up to 19 days post-dose
PK: Cmax of Midazolam
Time frame: Predose on day 1 up to 19 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3839840 and Midazolam in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.