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Completed

NCT Number: NCT06594159

A Study of LY4065967 in Healthy Japanese Participants

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4065967

Drug

Administered orally

Placebo

Drug

Administered orally

Rosuvastatin

Drug

Administered orally

Primary outcomes

  1. 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

    Time frame: Baseline to 7 Days

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

  2. 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

    Time frame: Baseline to 12 Days

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

  3. Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin

    Time frame: Predose on Day 1 Through 72 Hours Post-Dose

    Part D: PK: Cmax of Rosuvastatin

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

    Time frame: Predose on Day 1 Through 72 Hours Post-Dose

    Part D: PK: AUC of Rosuvastatin

Secondary outcomes

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

    Time frame: Predose on Day 1 Through 48 Hours Post-Dose

    Part A: PK: Cmax of LY4065967

  2. Part B: PK: Cmax of LY4065967

    Time frame: Predose on Day 1 Through Day 9

    Part B: PK: Cmax of LY4065967

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

    Time frame: Predose on Day 1 Through 48 Hours Post-Dose

    Part A and B: PK: AUC of LY4065967

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

    Time frame: Day 5 Through Day 11

    Part D: PK: Cmax of LY4065967

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

    Time frame: Day 5 Through Day 11

    Part D: PK: AUC of LY4065967

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967, to Evaluate the Effect of LY4065967 on the Pharmacokinetics of Rosuvastatin in Healthy Japanese Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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