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A Study of LY2409021 Formulations and the Effect of Food

NCT01354496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-03-11

Study results available
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Summary

The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.

The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.

There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.

Conditions

  • Healthy Volunteers

Interventions

DRUG

LY2409021 Reference Form

Administered orally

DRUG

LY2409021 Test-Med Formulation (medium particle size)

Administered orally

DRUG

LY2409021 Test-High Formulation (high particle size)

Administered orally

DRUG

LY2409021 Test-Low Formulation (low particle size)

Administered orally

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354496 on ClinicalTrials.gov