A Study of LY900020 in Healthy Chinese Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY900020; Drug: Metformin XR; Drug: Atorvastatin; Drug: Valsartan

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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• Have previously participated or withdrawn from this study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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): February 18, 2020
• Study Completion (Actual): February 18, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Atorvastatin; Valsartan; Metformin
• Other Study ID Numbers: 16968; I9J-MC-DIPA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes