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Completed

NCT Number: NCT04047940

A Study of LY900020 in Healthy Chinese Participants

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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Key information

Conditions

Healthy

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY900020

Drug

Administered orally

Metformin XR

Drug

Administered orally

atorvastatin

Drug

Administered orally

valsartan

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY900020

    Time frame: Predose through 72 hours postdose on Day 4 in each study arm

    PK: AUC of LY900020

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY900020

    Time frame: Predose through 72 hours postdose on Day 4 in each study arm

    PK: Cmax of LY900020

Secondary outcomes

  1. PK: Time to Maximum Observed Drug Concentration (tmax) of LY900020

    Time frame: Predose through 72 hours postdose on Day 4 in each study arm

    PK: Tmax of LY900020

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2019
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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