Healthy
Conditions
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 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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Part A and B-Double-blinded Part A3 and D-Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 D: PK: Maximum Concentration (Cmax) of Rosuvastatin | 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 | Predose on Day 1 Through 72 Hours Post-Dose | Part D: PK: AUC of Rosuvastatin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 | Predose on Day 1 Through 48 Hours Post-Dose | Part A: PK: Cmax of LY4065967 |
| Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967 | Day 5 Through Day 11 | Part D: PK: AUC of LY4065967 |
| Part B: PK: Cmax of LY4065967 | Predose on Day 1 Through Day 9 | Part B: PK: Cmax of LY4065967 |
| Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967 | Predose on Day 1 Through 48 Hours Post-Dose | Part A and B: PK: AUC of LY4065967 |
| Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967 | Day 5 Through Day 11 | Part D: PK: Cmax of LY4065967 |
Countries
Japan
Outcome results
None listed