A Study of LY900020 in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Valsartan; Drug: LY900020; Drug: Atorvastatin; Drug: Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT04047940

16968

I9J-MC-DIPA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

LY900020 Formulation 1

Experimental group

Description:

LY900020 Formulation 1 administered orally

Treatment:

Drug: LY900020

LY900020 Formulation 2

Experimental group

Description:

LY900020 Formulation 2 administered orally

Treatment:

Drug: LY900020

LY900020 Formulation 3

Experimental group

Description:

LY900020 Formulation 3 administered orally

Treatment:

Drug: LY900020

Reference Drugs

Active Comparator group

Description:

Metformin XR, atorvastatin, and valsartan administered orally

Treatment:

Drug: Metformin XR

Drug: Valsartan

Drug: Atorvastatin