A Study of LY3526318 in Healthy Male Japanese Participants
Phase 1
Withdrawn
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05580250
- Lead Sponsor
- Eli Lilly and Company
- Brief 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). Participants may only enroll in one part. After screening, the study will last from one to two weeks, depending on part.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Single Dose Placebo Placebo Placebo administered orally in three study periods. Part B: Multiple Dose Placebo Placebo Placebo administered orally. Part B: Multiple Dose LY3526318 LY3526318 LY3526318 administered orally. Part A: Single Dose LY3526318 LY3526318 LY3526318 administered orally in three study periods. Part C: Iohexol + Simvastatin + Metformin + LY3526318 LY3526318 Iohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally. Part C: Iohexol + Simvastatin + Metformin + LY3526318 Iohexol Iohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally. Part C: Iohexol + Simvastatin + Metformin + LY3526318 Simvastatin Iohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally. Part C: Iohexol + Simvastatin + Metformin + LY3526318 Metformin Iohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally.
- Primary Outcome Measures
Name Time Method 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 Baseline through Day 12 A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Metformin Predose on Day -2 through Day 8 PK: Cmax of metformin.
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin Predose on Day -2 through Day 8 PK: AUC of metformin.
Part C: PK: Total Body Clearance (CL) of Iohexol Predose on Day -5 through Day 4 PK: CL of Iohexol.
Part C: PK: Cmax of Simvastatin Predose on Day -4 through Day 6 PK: Cmax of simvastatin.
Part C: PK: AUC of Simvastatin Predose on Day -4 through Day 6 PK: AUC of Simvastatin.
Part C: PK: Cmax of Simvastatin Acid Predose on Day -4 through Day 6 PK: Cmax of Simvastatin Acid.
Part C: PK: AUC of Simvastatin Acid Predose on Day -4 through Day 6 PK: AUC of Simvastatin Acid.
- Secondary Outcome Measures
Name Time Method Part A, B, and C: PK: AUC of LY3526318 Predose on Day 1 up to Day 14 PK: AUC of LY3526318.
Part A, B, and C: PK: Cmax of LY3526318 Predose on Day 1 up to Day 14 PK: Cmax of LY3526318.
Trial Locations
- Locations (1)
Souseikai Fukuoka Mirai Hospital
🇯🇵Fukuoka, Japan