Healthy
Conditions
Brief summary
This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will last about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Interventions
DRUGLY900020
Administered orally
DRUGMetformin XR
Administered orally
DRUGAtorvastatin
Administered orally
DRUGValsartan
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * Have a body mass index (BMI) of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
Exclusion criteria
* 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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to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 * Had blood loss of more than 400 milliliters (mL) within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm | PK: AUC of LY900020 |
| PK: Maximum Observed Drug Concentration (Cmax) of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm | PK: Cmax of LY900020 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm | PK: Tmax of LY900020 |
Countries
Singapore
Outcome results
None listed