Can a new oral drug pass early safety tests?

NCT ID NCT05580250

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers are testing an experimental oral drug called LY3526318 in healthy Japanese men to see if it is safe and well tolerated. The study also measures how the drug affects the kidneys and liver by checking how the body handles other medications like metformin and simvastatin. Participants receive either LY3526318 or a placebo, and the trial is divided into three parts, with each person joining only one part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3526318, an experimental oral drug
What this could lead to
If successful, this early study could support further development of LY3526318 as a potential treatment, though its intended disease target is not yet disclosed.
What could go wrong
This is a small, early-phase safety study in healthy volunteers, so it cannot prove the drug works for any condition. Side effects or unexpected drug interactions may emerge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Nov 2022

An estimate. Start dates often move.

Expected to finish

Dec 2022

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, 813-0017, Japan

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