A Study of LY900020 in Healthy Chinese Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-29

Study Completion Date

2020-02-18

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY900020 Formulation 1

LY900020 Formulation 1 administered orally

Group Type EXPERIMENTAL

LY900020

Intervention Type DRUG

Administered orally

LY900020 Formulation 2

LY900020 Formulation 2 administered orally

Group Type EXPERIMENTAL

LY900020

Intervention Type DRUG

Administered orally

LY900020 Formulation 3

LY900020 Formulation 3 administered orally

Group Type EXPERIMENTAL

LY900020

Intervention Type DRUG

Administered orally

Reference Drugs

Metformin XR, atorvastatin, and valsartan administered orally

Group Type ACTIVE_COMPARATOR

Metformin XR

Intervention Type DRUG

Administered orally

Atorvastatin

Intervention Type DRUG

Administered orally

Valsartan

Intervention Type DRUG

Administered orally

Interventions

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LY900020

Administered orally

Intervention Type DRUG

Metformin XR

Administered orally

Intervention Type DRUG

Atorvastatin

Administered orally

Intervention Type DRUG

Valsartan

Administered orally

Intervention Type DRUG

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes