HealthyPhase 1NCT06503679
A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants
A Phase 1 study testing LY4100511 (DC-853) Dose 1, LY4100511 (DC-853) Dose 2 and LY4100511 (DC-853) Dose 3 in people with Healthy, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY4100511 (DC-853) Dose 1, LY4100511 (DC-853) Dose 2 and LY4100511 (DC-853) Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 31 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females must be of childbearing potential
- Males must agree to use contraception
- Have body mass index (BMI) between 18.0 and 32.0 kilogram/square meter (kg/m²), inclusive, and a body weight of greater than or equal to 50 kg.
- In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clincial laboratory evaluations (congentical nonhemolytic hyperbilirubinemia) at screening and check-in, and from the physical examination at check-in as assessed by the investigator.
Who cannot join
- Have a 12-lead ECG abnormality that, in the opinion of the investigator,
- increases the risks associated with participating in the study
- may confound ECG data analysis
- a QTCF >450 msec for males, or >470 msec for females
- short PR interval <120 msec or PR interval >220 msec
- second or third degree atrioventricular block
Show all 16Show fewer
- intraventricular conduction delay with QRS >120 msec
- complete right bundle branch block
- left bundle branch block, or
- Wolff Parkinson-White syndrome.
- Have had current or recent acute infection
- Show evidence of active or latent tuberculosis (TB)
- Had any surgical procedures within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study.
- Have a history or presence of multiple or severe allergies, or an anaphylactic reaction to prescription or non prescription drugs.
- Are immunocompromised
- Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-center, Open-label, Fixed-sequence, Crossover Study to Evaluate the Effect of LY4100511 (DC-853) on the Single-dose Pharmacokinetics of Midazolam, Repaglinide, Digoxin, and Rosuvastatin in Healthy Participants
The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4100511 (DC-853) Dose 1Drug
Administered orally
LY4100511 (DC-853) Dose 2Drug
Administered orally
LY4100511 (DC-853) Dose 3Drug
Administered orally
MidazolamDrug
Administered orally
RepaglinideDrug
Administered orally
DigoxinDrug
Administered orally
RosuvastatinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) | Experimental | Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. Receives: Drug: LY4100511 (DC-853) Dose 1; Drug: Midazolam; Drug: Repaglinide |
| LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) | Experimental | Participants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed. Receives: Drug: LY4100511 (DC-853) Dose 2; Drug: Midazolam; Drug: Repaglinide |
| LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) | Experimental | Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. Receives: Drug: LY4100511 (DC-853) Dose 3; Drug: Digoxin; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Repaglinide, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Digoxin, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Midazolam, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Repaglinide,in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Digoxin, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Midazolam, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Repaglinide, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Digoxin, in the absence or presence of steady-state LY4100511
Measured: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start16 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of 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
- NCT06503679
- Sponsor's protocol ID
- 27110
- Other IDs
- J5C-MC-FOAF, DC-853104
- Status last verified
- Jan 2025
- First submitted
- 10 Jul 2024
- Last updated
- 24 Jan 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Fixed-sequence, Crossover Study to Evaluate the Effect of LY4100511 (DC-853) on the Single-dose Pharmacokinetics of Midazolam, Repaglinide, Digoxin, and Rosuvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT06503679
- Acronym / sponsor ID
- 27110
- Conditions
- Healthy
- Keywords
- LY4100511, DC-853
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jul 2024 (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 study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) | Experimental | Drug: LY4100511 (DC-853) Dose 1, Drug: Midazolam, Drug: RepaglinideParticipants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. |
| LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) | Experimental | Drug: LY4100511 (DC-853) Dose 2, Drug: Midazolam, Drug: RepaglinideParticipants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed. |
| LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) | Experimental | Drug: LY4100511 (DC-853) Dose 3, Drug: Digoxin, Drug: RosuvastatinParticipants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females must be of childbearing potential
- Males must agree to use contraception
- Have body mass index (BMI) between 18.0 and 32.0 kilogram/square meter (kg/m²), inclusive, and a body weight of greater than or equal to 50 kg.
- In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clincial laboratory evaluations (congentical nonhemolytic hyperbilirubinemia) at screening and check-in, and from the physical examination at check-in as assessed by the investigator.
Key exclusion criteria (16 listed)
- Have a 12-lead ECG abnormality that, in the opinion of the investigator,
- Have had current or recent acute infection
- Show evidence of active or latent tuberculosis (TB)
- Had any surgical procedures within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study.
- Have a history or presence of multiple or severe allergies, or an anaphylactic reaction to prescription or non prescription drugs.
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 |
|---|---|---|
| LY4100511 (DC-853) Dose 1Administered orally | Drug | LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) |
| LY4100511 (DC-853) Dose 2Administered orally | Drug | LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) |
| LY4100511 (DC-853) Dose 3Administered orally | Drug | LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) |
| MidazolamAdministered orally | Drug | LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1), LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) |
| RepaglinideAdministered orally | Drug | LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1), LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) |
| DigoxinAdministered orally | Drug | LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) |
| RosuvastatinAdministered orally | Drug | LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Repaglinide, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Digoxin, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Midazolam, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Repaglinide,in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Digoxin, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Midazolam, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Repaglinide, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Digoxin, in the absence or presence of steady-state LY4100511
Time frame: Day 1 and Day 9: Predose, Up to 48 Hours 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 24 Jan 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4100511 (DC-853) Dose 1, LY4100511 (DC-853) Dose 2 and LY4100511 (DC-853) Dose 3 in people with Healthy, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site 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 4 inclusion and 16 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam, in the absence or presence of steady-state LY4100511 (time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose). The study lists 12 primary outcomes in all. 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 24 Jan 2025.