NCT04047940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

August 6, 2019

Last Update Submit

March 2, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

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

Study Arms (4)

LY900020 Formulation 1

EXPERIMENTAL

LY900020 Formulation 1 administered orally

Drug: LY900020

LY900020 Formulation 2

EXPERIMENTAL

LY900020 Formulation 2 administered orally

Drug: LY900020

LY900020 Formulation 3

EXPERIMENTAL

LY900020 Formulation 3 administered orally

Drug: LY900020

Reference Drugs

ACTIVE COMPARATOR

Metformin XR, atorvastatin, and valsartan administered orally

Drug: Metformin XRDrug: AtorvastatinDrug: Valsartan

Interventions

LY900020DRUG

Administered orally

LY900020 Formulation 1LY900020 Formulation 2LY900020 Formulation 3
Metformin XRDRUG

Administered orally

Reference Drugs
AtorvastatinDRUG

Administered orally

Reference Drugs
ValsartanDRUG

Administered orally

Reference Drugs

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

AtorvastatinValsartan

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsTetrazolesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

November 29, 2019

Primary Completion

February 18, 2020

Study Completion

February 18, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)