A Study of LY900020 in Healthy Chinese Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047940
• Other study ID #: 16968
• Secondary ID: I9J-MC-DIPA
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2019
• Est. completion date: February 18, 2020

Study information

• Verified date: March 1, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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• Have previously participated or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY900020
Administered orally
• Metformin XR
Administered orally
• Atorvastatin
Administered orally
• Valsartan
Administered orally

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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