Status:
COMPLETED
A Study of LY4065967 in Healthy Japanese Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06594159
Start Date
October 22 2024
End Date
March 11 2025
Last Update
April 3 2025
Active Locations (1)
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1
Souseikai Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017