Can a new oral drug pass early safety tests?
NCT ID NCT05580250
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
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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