A Study of LY2409021 Formulations in Healthy Participants

Healthy Clinical Trial

Official title:

A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02385084
• Other study ID #: 15709
• Secondary ID: I1R-MC-GLDM
• Status: Terminated
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: May 2015

Study information

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

Clinical Trial Summary

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination

• Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)

• Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

• Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy

• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

• Have known or ongoing psychiatric disorders

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY2409021
Administered orally

Locations

Country	Name	City	State
United States	Covance CRU, Inc	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 (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021		Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
Primary	PK: Maximum Plasma Concentration (Cmax) of LY2409021		Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period