A Study of LY3526318 in Healthy Male Japanese Participants

NCT ID: NCT05580250

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2022-12-08

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part A: Single Dose LY3526318

LY3526318 administered orally in three study periods.

Group Type: EXPERIMENTAL

LY3526318

Intervention Type: DRUG

Administered orally.

Part A: Single Dose Placebo

Placebo administered orally in three study periods.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Part B: Multiple Dose LY3526318

LY3526318 administered orally.

Group Type: EXPERIMENTAL

LY3526318

Intervention Type: DRUG

Administered orally.

Part B: Multiple Dose Placebo

Placebo administered orally.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Part C: Iohexol + Simvastatin + Metformin + LY3526318

Iohexol administered intravenously (IV) and simvastatin, metformin, and LY3526318 administered orally.

Group Type: EXPERIMENTAL

LY3526318

Intervention Type: DRUG

Administered orally.

Iohexol

Intervention Type: DRUG

Administered intravenously (IV).

Simvastatin

Intervention Type: DRUG

Administered orally.

Metformin

Intervention Type: DRUG

Administered orally.

Interventions

LY3526318

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Iohexol

Administered intravenously (IV).

Intervention Type: DRUG

Simvastatin

Administered orally.

Intervention Type: DRUG

Metformin

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Souseikai Fukuoka Mirai Hospital

Fukuoka, , Japan

Countries

Japan

Other Identifiers

J2D-JE-CVAD

Identifier Type: OTHER

Identifier Source: secondary_id

18353

Identifier Type: -

Identifier Source: org_study_id