A Study of LY900020 in Healthy Chinese Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Relative Bioavailability Study of Three LY900020 Tablet Formulations in Healthy Chinese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY900020
* Drug: Metformin XR
* Drug: Atorvastatin
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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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30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY900020 Formulation 1<br>LY900020 Formulation 1 administered orally | Drug: LY900020<br>* Administered orally<br>|
| Experimental: LY900020 Formulation 2<br>LY900020 Formulation 2 administered orally | Drug: LY900020<br>* Administered orally<br>|
| Experimental: LY900020 Formulation 3<br>LY900020 Formulation 3 administered orally | Drug: LY900020<br>* Administered orally<br>|
| Active Comparator: Reference Drugs<br>Metformin XR, atorvastatin, and valsartan administered orally | Drug: Metformin XR<br>* Administered orally<br>Drug: Atorvastatin<br>* Administered orally<br>Drug: Valsartan<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020 | PK: AUC of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY900020 | PK: Cmax of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020 | PK: Tmax of LY900020 | Predose through 72 hours postdose on Day 4 in each study arm |