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HealthyPhase 1NCT05580250

A Study of LY3526318 in Healthy Male Japanese Participants

A Phase 1 study testing LY3526318, Iohexol and Simvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a study of LY3526318 in healthy male Japanese. The main purposes of this study are to: Assess how safe and well tolerated LY3526318 is when given by mouth. Measure how LY3526318 affects the kidney and the liver. The study will be conducted in three parts (Part A, Part B, Part C). Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3526318, Iohexol and Simvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteJapan
Study dates
Nov 2022to Dec 2022
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
  • Body weight of at least 50 kilogram (kg) and body mass index within the range 18 to 30 kilogram per square meter (kg/m2).
  • Male participants must adhere to the contraceptive requirements.
  • Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged not clinically significant by the investigator.

Who cannot join

  • Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study. In addition, participants with the following finding will be excluded:
  • Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions.
  • Show evidence of human immunodeficiency virus and/or positive human immunodeficiency virus antigens and/or antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
  • Show evidence of syphilis or have a positive syphilis test.
  • Have an abnormal blood pressure (supine) as determined by the investigator.
Show all 14Show fewer
  • Are unwilling to stop herbal supplements, over-the-counter, or prescription medicines, including drugs that are known inducers or inhibitors of cytochrome P450 3A4 (CYP3A4), within 14 days prior to study intervention administration and for the duration of the study. An exception is for acetaminophen at doses of less than or equal to (≤3) grams/day.
  • Participated (defined as last dose of study drug) within 30 days prior to dosing in a clinical trial involving an investigational product or nonapproved use of a drug with a short half-life, or within 5 half-lives of an investigational product with a half-life longer than 6 days.
  • Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission.
  • Are unwilling to comply with the required dietary restrictions.
  • Additional Exclusion Criteria of Part C:
  • Have known allergies to iohexol, iodine, simvastatin, metformin, and related compounds or any components of the formulation.
  • Show evidence of CYP3A5 *1 allele (CYP3A5*1/*1 or CYP3A5*1/*3).
  • Confirmed creatinine clearance <90 milliliter per minute (mL/min) at the screening period assessment.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, 813-0017

Other trials in Japan

About this study

Official title: A Phase I, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of LY3526318, and to Investigate the Effect of LY3526318 on Metformin and Simvastatin Pharmacokinetics in Healthy Male Japanese Participants

This is a study of LY3526318 in healthy male Japanese. The main purposes of this study are to:

  • Assess how safe and well tolerated LY3526318 is when given by mouth.
  • Measure how LY3526318 affects the kidney and the liver. The study will be conducted in three parts (Part A, Part B, Part C). Participants may only enroll in one part. After screening, the study will last from one to two weeks, depending on part.
Conditions
Healthy
Being tested
LY3526318, Placebo, Iohexol, Simvastatin, Metformin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3526318Drug

    Administered orally.

  • PlaceboDrug

    Administered orally.

  • IohexolDrug

    Administered intravenously (IV).

  • SimvastatinDrug

    Administered orally.

  • MetforminDrug

    Administered orally.

Study groups in NCT05580250
Study groupRoleWhat they receive
Part A: Single Dose LY3526318ExperimentalLY3526318 administered orally in three study periods.
Receives: Drug: LY3526318
Part A: Single Dose PlaceboPlacebo comparatorPlacebo administered orally in three study periods.
Receives: Drug: Placebo
Part B: Multiple Dose LY3526318ExperimentalLY3526318 administered orally.
Receives: Drug: LY3526318
Part B: Multiple Dose PlaceboPlacebo comparatorPlacebo administered orally.
Receives: Drug: Placebo
Part C: Iohexol + Simvastatin + Metformin + LY3526318ExperimentalIohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally.
Receives: Drug: LY3526318; Drug: Iohexol; Drug: Simvastatin; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and B: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

    Measured: Baseline through Day 12

  2. Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Metformin

    PK: Cmax of metformin.

    Measured: Predose on Day -2 through Day 8

  3. Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin

    PK: AUC of metformin.

    Measured: Predose on Day -2 through Day 8

  4. Part C: PK: Total Body Clearance (CL) of Iohexol

    PK: CL of Iohexol.

    Measured: Predose on Day -5 through Day 4

  5. Part C: PK: Cmax of Simvastatin

    PK: Cmax of simvastatin.

    Measured: Predose on Day -4 through Day 6

  6. Part C: PK: AUC of Simvastatin

    PK: AUC of Simvastatin.

    Measured: Predose on Day -4 through Day 6

  7. Part C: PK: Cmax of Simvastatin Acid

    PK: Cmax of Simvastatin Acid.

    Measured: Predose on Day -4 through Day 6

  8. Part C: PK: AUC of Simvastatin Acid

    PK: AUC of Simvastatin Acid.

    Measured: Predose on Day -4 through Day 6

Secondary outcomes (2)

  1. Part A, B, and C: PK: Cmax of LY3526318

    PK: Cmax of LY3526318.

    Measured: Predose on Day 1 up to Day 14

  2. Part A, B, and C: PK: AUC of LY3526318

    PK: AUC of LY3526318.

    Measured: Predose on Day 1 up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study startNov 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Why it stopped: The sponsor made a business decision to withdraw the trial.

Resources

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580250
Sponsor's protocol ID
18353
Other IDs
J2D-JE-CVAD
Status last verified
Sep 2026
First submitted
12 Oct 2022
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3526318, Iohexol and Simvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.

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 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: withdrawn, as of the sponsor's last update on 8 Sep 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 Japan. 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 was withdrawn before enrolling participants, so there are no results.

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?

Part A and B: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 12). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580250.

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 8 Sep 2026.

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