A Study of LY4065967 in Healthy Japanese Participants

JRCT ID: jRCT2071240067

Registered date:02/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy
• Date of first enrollment: 10/10/2024
• Target sample size: 69
• Study type: Interventional

Intervention(s)

DRUG: LY4065967
Administered orally
DRUG: Placebo
Administered orally
DRUG: Rosuvastatin
Administered orally

[Study Arms]
Experimental: LY4065967 Part A
A single dose of LY4065967 administered orally
Interventions:
Drug: LY4065967
Placebo Comparator: Placebo Part A
Placebo administered orally
Interventions:
Drug: Placebo
Experimental: LY4065967 Part B
Multiple doses of LY4065967 administered orally
Interventions:
Drug: LY4065967
Placebo Comparator: Placebo Part B
Placebo administered orally
Interventions:
Drug: Placebo
Experimental: LY4065967 Part C
LY4065967 administered orally
Interventions:
Drug: LY4065967
Experimental: LY4065967 and Rosuvastatin Part D
LY4065967 and Rosuvastatin administered orally
Interventions:
Drug: LY4065967
Drug: Rosuvastatin

Outcome(s)

Primary Outcome

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

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

Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 [ Time Frame: Predose on Day 1 Through 48 Hours Post-Dose ]
Part C: PK: Cmax of LY4065967
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967 [ Time Frame: Predose on Day 1 Through 48 Hours Post-Dose ]
Part C: PK: AUC of LY4065967

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
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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Wakayama Naohiko
• Secondary ID(s): NCT06594159