CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
LY2409021 Reference Form +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01354496
NCT01354496Phase 1Completed
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LY2409021 Formulation Bridging and Food Effect Study

Eli Lilly and Company·interventional·Posted May 17, 2011·Updated Mar 11, 2019

In Brief

A Phase 1 clinical trial evaluating LY2409021 Reference Form, LY2409021 Test-Med Formulation (medium particle size), and 2 other interventions for Healthy Volunteers. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesSingapore
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2011
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.1 years ago

Interventions

LY2409021 Reference Formdrug

Administered orally

LY2409021 Test-Med Formulation (medium particle size)drug

Administered orally

LY2409021 Test-High Formulation (high particle size)drug

Administered orally

LY2409021 Test-Low Formulation (low particle size)drug

Administered orally