CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
LY2216684 +1 moredrug
Likely dose
LY2216684 18 mgfrom 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/NCT01243957
NCT01243957Phase 1Completed

LY2216684 and Fluoxetine Pharmacokinetic Interaction Study in Healthy Subjects

Eli Lilly and Company·interventional·Posted Nov 19, 2010·Updated Jan 29, 2019

In Brief

A Phase 1 clinical trial evaluating LY2216684 and Fluoxetine for Major Depressive Disorder. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to measure if there is any difference in how the body breaks down or inactivates either fluoxetine or LY2216684 when both of these medicines are given together. This study will look at how fluoxetine might affect LY2216684 and how giving LY2216684 might affect fluoxetine in the body. The duration of study participation in this study is approximately 36 days not including the screening appointment. This study requires 1 research unit confinement of 29 days/28 nights followed by 1 outpatient appointment. A screening appointment is required within 30 days prior to the start of the study.

Study Details

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

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.6 years ago

Interventions

LY2216684drug

LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27

Fluoxetinedrug

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)