A Study of LY900020 in Healthy Chinese Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04047940
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.7
• Patients Per Site Per Month: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY900020; Drug: Metformin XR; Drug: Atorvastatin; Drug: Valsartan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Relative Bioavailability Study of Three LY900020 Tablet Formulations in Healthy Chinese Subjects
• Actual Study Start Date: Nov 29, 2019
• Actual Primary Completion Date: Feb 18, 2020
• Actual Study Completion Date: Feb 18, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lilly Centre for Clinical Pharmacology	Singapore		Singapore	138623

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04047940
• Other Study ID Numbers: 16968; I9J-MC-DIPA
• First Posted: Aug 7, 2019
• Last Update Posted: Mar 3, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Metformin; Valsartan; Atorvastatin

Study Results

No Results Posted as of Mar 3, 2020