A Study of LY3526318 in Healthy Male Japanese Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05580250
• Other study ID #: 18353
• Secondary ID: J2D-JE-CVAD
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 22, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: January 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Participants may only enroll in one part. After screening, the study will last from one to two weeks, depending on part.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3526318
Administered orally.
• Placebo
Administered orally.
• Iohexol
Administered intravenously (IV).
• Simvastatin
Administered orally.
• Metformin
Administered orally.

Locations

Country	Name	City	State
Japan	Souseikai Fukuoka Mirai Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Day 12
Primary	Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Metformin	PK: Cmax of metformin.	Predose on Day -2 through Day 8
Primary	Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin	PK: AUC of metformin.	Predose on Day -2 through Day 8
Primary	Part C: PK: Total Body Clearance (CL) of Iohexol	PK: CL of Iohexol.	Predose on Day -5 through Day 4
Primary	Part C: PK: Cmax of Simvastatin	PK: Cmax of simvastatin.	Predose on Day -4 through Day 6
Primary	Part C: PK: AUC of Simvastatin	PK: AUC of Simvastatin.	Predose on Day -4 through Day 6
Primary	Part C: PK: Cmax of Simvastatin Acid	PK: Cmax of Simvastatin Acid.	Predose on Day -4 through Day 6
Primary	Part C: PK: AUC of Simvastatin Acid	PK: AUC of Simvastatin Acid.	Predose on Day -4 through Day 6
Secondary	Part A, B, and C: PK: Cmax of LY3526318	PK: Cmax of LY3526318.	Predose on Day 1 up to Day 14
Secondary	Part A, B, and C: PK: AUC of LY3526318	PK: AUC of LY3526318.	Predose on Day 1 up to Day 14