HealthyPhase 1NCT07592572
A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants
A Phase 1 study testing LY4395089 and Itraconazole in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of the study is to see how itraconazole affects LY4395089 in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. There will be fifteen inpatient stays at the clinical research unit (CRU). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY4395089 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 8 Jul 2026
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs)
- Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram per square meter (kg/m²) (inclusive)
- Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individual not of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow clinical research unit (CRU)-specific study procedures
Who cannot join
- Have a significant history or presence of the following conditions:
- rheumatologic
- Cardiovascular (CV), including congestive heart failure
- respiratory
- hepatic, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum total bilirubin level (TBL) above 1.25 × upper limit of normal (ULN) per the laboratory's reference range at screening or admission
- renal
Show all 17Show fewer
- gastrointestinal (GI)
- endocrine, including Cushing syndrome, hyperthyroidism, and hyperaldosteronism
- hematological, or
- neurological disorders
- Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information, such as prior history of hypersensitivity to itraconazole or other -azoles
- Have any abnormalities identified following a physical examination that, in the opinion of the investigator, would jeopardize the safety of the participant or interfere with study conduct if they took part in the study
- Have a positive hepatitis C virus (HCV) antibody test
- Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antigen or antibodies
- Show evidence of hepatitis B or positive hepatitis B surface antigen
- Have alcohol intake that exceeds the recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator, or a positive ethanol test at screening or admission
- Have smoked, or used tobacco or nicotine-containing products, in the 3 months prior to study intervention administration, or have a positive cotinine test at screening or admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of LY4395089 in Healthy Participants
The purpose of the study is to see how itraconazole affects LY4395089 in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
There will be fifteen inpatient stays at the clinical research unit (CRU). The study will last about 2 weeks.
- Conditions
- Healthy
- Being tested
- LY4395089, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4395089Drug
Administered orally
ItraconazoleDrug
Administered orally
ItraconazoleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4395089 | Experimental | LY4395089 administered orally Receives: Drug: LY4395089 |
| Itraconazole | Experimental | Itraconazole administered orally Receives: Drug: Itraconazole |
| LY4395089 + Itraconazole | Experimental | LY4395089 and Itraconazole administered orally Receives: Drug: LY4395089; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089
Measured: Baseline up to Day 15
PK: Maximum Concentration (Cmax) of LY4395089
Measured: Baseline up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start20 May 2026
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592572
- Sponsor's protocol ID
- 27808
- Other IDs
- J6P-MC-NFAC
- Status last verified
- Aug 2026
- First submitted
- 12 May 2026
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of LY4395089 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07592572
- Acronym / sponsor ID
- 27808
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 18 May 2026 (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 purpose of the study is to see how itraconazole affects LY4395089 in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
There will be fifteen inpatient stays at the clinical research unit (CRU). The study will last about 2 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY4395089 | Experimental | Drug: LY4395089LY4395089 administered orally |
| Itraconazole | Experimental | Drug: ItraconazoleItraconazole administered orally |
| LY4395089 + Itraconazole | Experimental | Drug: LY4395089, Drug: ItraconazoleLY4395089 and Itraconazole administered orally |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs)
- Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram per square meter (kg/m²) (inclusive)
- Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individual not of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow clinical research unit (CRU)-specific study procedures
Key exclusion criteria (17 listed)
- Have a significant history or presence of the following conditions:
- Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information, such as prior history of hypersensitivity to itraconazole or other -azoles
- Have any abnormalities identified following a physical examination that, in the opinion of the investigator, would jeopardize the safety of the participant or interfere with study conduct if they took part in the study
- Have a positive hepatitis C virus (HCV) antibody test
- Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antigen or antibodies
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 |
|---|---|---|
| LY4395089Administered orally | Drug | LY4395089, LY4395089 + Itraconazole |
| ItraconazoleAdministered orally | Drug | Itraconazole |
| ItraconazoleAdministered orally | Drug | LY4395089 + Itraconazole |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089
Time frame: Baseline up to Day 15
PK: Maximum Concentration (Cmax) of LY4395089
Time frame: Baseline up to Day 15
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 25 Aug 2026.
- 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 8 AM - 8 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 LY4395089 and Itraconazole in people with Healthy, run by 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 17 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 25 Aug 2026. 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 versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089 (time frame: Baseline up to Day 15). The study lists 2 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 25 Aug 2026.