A Study of LY900020 in Healthy Chinese Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY900020; Drug: Metformin XR; Drug: Atorvastatin; Drug: Valsartan

• Registration Number: NCT04047940
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2019-11-29
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Status Verified: 2020-03-01
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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• Have previously participated or withdrawn from this study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900020 Formulation 2	LY900020	LY900020 Formulation 2 administered orally
Reference Drugs	Metformin XR	Metformin XR, atorvastatin, and valsartan administered orally
LY900020 Formulation 1	LY900020	LY900020 Formulation 1 administered orally
LY900020 Formulation 3	LY900020	LY900020 Formulation 3 administered orally
Reference Drugs	Atorvastatin	Metformin XR, atorvastatin, and valsartan administered orally
Reference Drugs	Valsartan	Metformin XR, atorvastatin, and valsartan administered orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore