A Safety Study of LY3372689 in Healthy Participants
- Conditions
- Healthy
- Interventions
- Drug: PlaceboDrug: LY3372689
- Registration Number
- NCT04106206
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study is being conducted to determine the safety profile of the study drug after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3372689 or placebo and will remain in the study for up to eight weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Overtly healthy vasectomized male or a female who cannot get pregnant
- Have a body mass index (BMI) of 18.5 to ≤30 kilograms per square meter (kg/m²)
- Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for ease of blood sampling
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered orally LY3372689 LY3372689 LY3372689 administered orally
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration Baseline through final follow-up at approximately Day 30 A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372689 Day 1 postdose through Day 15 PK: Cmax of LY3372689
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372689 Day 1 postdose through Day 15 PK: AUC of LY3372689
Trial Locations
- Locations (1)
Covance
🇺🇸Dallas, Texas, United States