A Study of LY4065967 in Healthy Japanese Participants

NCT06594159 | Completed Phase 1

• 2 other identifiers: 18815J4X-JE-LWCA
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration

  Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline to 7 Days

• Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration

  Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline to 12 Days

• Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin

  Part D: PK: Cmax of Rosuvastatin

  Predose on Day 1 Through 72 Hours Post-Dose

• Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin

  Part D: PK: AUC of Rosuvastatin

  Predose on Day 1 Through 72 Hours Post-Dose

Secondary Outcomes (5)

• Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967

  Predose on Day 1 Through 48 Hours Post-Dose

• Part B: PK: Cmax of LY4065967

  Predose on Day 1 Through Day 9

• Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967

  Predose on Day 1 Through 48 Hours Post-Dose

• Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967

  Day 5 Through Day 11

• Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967

  Day 5 Through Day 11

Study Arms (5)

LY4065967 Part A

EXPERIMENTAL

A single dose of LY4065967 administered orally

Drug: LY4065967

Placebo Part A

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

LY4065967 Part B

EXPERIMENTAL

Multiple doses of LY4065967 administered orally

Drug: LY4065967

Placebo Part B

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

LY4065967 and Rosuvastatin Part D

EXPERIMENTAL

LY4065967 and Rosuvastatin administered orally

Drug: LY4065967; Drug: Rosuvastatin

Interventions

LY4065967 DRUG

Administered orally

LY4065967 Part A; LY4065967 Part B; LY4065967 and Rosuvastatin Part D

Placebo DRUG

Administered orally

Placebo Part A; Placebo Part B

Rosuvastatin DRUG

Administered orally

LY4065967 and Rosuvastatin Part D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
• Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)
• Have a body weight of:
• ≥ 40 kilograms (kg) for individuals assigned female at birth
• ≥ 50 kg for individuals assigned male at birth

You may not qualify if:

• 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 echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study
• Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies.
• Show evidence of 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 pregnant or intend to become pregnant or to breastfeed during the study.
• 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
• Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
• Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes
• Are unwilling to comply with the dietary restrictions required for this study

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Call 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A and B-Double-blinded Part A3 and D-Open-label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 22, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)