Clinical trial NCT06594159: A Study of LY4065967 in Healthy Japanese Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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:

* 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

Primary outcomes:
measure: 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
timeFrame: Baseline to 7 Days
measure: 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
timeFrame: Baseline to 12 Days
measure: Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin
timeFrame: Predose on Day 1 Through 72 Hours Post-Dose
measure: Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin
timeFrame: Predose on Day 1 Through 72 Hours Post-Dose
Secondary outcomes:
measure: Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967
timeFrame: Predose on Day 1 Through 48 Hours Post-Dose
measure: Part B: PK: Cmax of LY4065967
timeFrame: Predose on Day 1 Through Day 9
measure: Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967
timeFrame: Predose on Day 1 Through 48 Hours Post-Dose
measure: Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967
timeFrame: Day 5 Through Day 11
measure: Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967
timeFrame: Day 5 Through Day 11
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Souseikai Fukuoka Mirai Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: