A Study of LY4065967 in Healthy Japanese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Rosuvastatin; Drug: LY4065967

Study type: Interventional

Funder types: Industry

Identifiers

NCT06594159

J4X-JE-LWCA (Other Identifier)

18815

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 5 patient groups, including a placebo group

LY4065967 Part A

Experimental group

Description:

A single dose of LY4065967 administered orally

Treatment:

Drug: LY4065967

Placebo Part A

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

LY4065967 Part B

Experimental group

Description:

Multiple doses of LY4065967 administered orally

Treatment:

Drug: LY4065967

Placebo Part B

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

LY4065967 and Rosuvastatin Part D

Experimental group

Description:

LY4065967 and Rosuvastatin administered orally

Treatment:

Drug: LY4065967

Drug: Rosuvastatin