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A Study of LY4065967 in Healthy Japanese Participants

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 - J4X-JE-LWCA

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071240067
Enrollment
59
Registered
2024-10-02
Start date
2024-10-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Interventions

DRUG: LY4065967 Administered orally DRUG: Placebo Administered orally DRUG: Rosuvastatin Administered orally [Study Arms] Experimental: LY4065967 Part A A single dose of LY4065967 administere

Sponsors

Wakayama Naohiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 [Time Frame: 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 [Time Frame: Baseline to 12 Days] Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin Part D: PK: Cmax of Rosuvastatin [Time Frame: 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 [Time Frame: Predose on Day 1 Through 72 Hours Post-Dose]

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026