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NCT02217618 Clinical Trial

A Study of LY2409021 in Healthy Participants

Healthy Participants Clinical Trial

Official title:
A Single Dose Pharmacokinetic Study of LY2409021 Tablet Administered in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02217618
Other study ID # 14580
Secondary ID I1R-MC-GLDL
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2014
Est. completion date September 2014

Study information
Verified date March 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Healthy males or females as determined by medical history

- Satisfactory clinical laboratory and physical examination tests

- Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m^2)

Exclusion Criteria:

- Abnormal electrocardiograms (ECGs)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY2409021

Locations
Country Name City State
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Daytona Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 Area under the concentration versus time curve from zero to infinity (AUC[0-inf]) of LY2409021 is presented. Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Primary Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Primary Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021 Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
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