CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
LY2216684drug
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/NCT01241435
NCT01241435Phase 1Completed

The Effect of Impaired Hepatic Function on the Pharmacokinetics of LY2216684

Eli Lilly and Company·interventional·Posted Nov 16, 2010·Updated Oct 22, 2018

In Brief

A Phase 1 clinical trial evaluating LY2216684 for Depressive Disorder, Major. Completed, enrolled 36 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study. The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.6 years ago

Interventions

LY2216684drug

Administered orally