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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Page 1 of 1 (1 locations)

1

Souseikai Fukuoka Mirai Hospital

Fukuoka, Japan, 813-0017