CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Baricitinib +2 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/NCT01924299
NCT01924299Phase 1Completed
CompareCT.gov

The Effect of Ketoconazole or Fluconazole on the Pharmacokinetics of Baricitinib in Healthy Subjects

Eli Lilly and Company·interventional·Posted Aug 16, 2013·Updated Jun 6, 2017

In Brief

A Phase 1 clinical trial evaluating Baricitinib, Ketoconazole, and 1 other intervention for Healthy Volunteers. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The main purpose of this study is to look at the effect of ketoconazole and fluconazole on how much baricitinib gets into the blood stream. The study will also look at the tolerability of baricitinib and ketoconazole when given together and the tolerability of baricitinib and fluconazole when given together. Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each treatment group will participate in 2 study periods. Participants will take baricitinib alone in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This study will last approximately 7 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 16, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.9 years ago

Interventions

Baricitinibdrug

Administered orally

Ketoconazoledrug

Administered orally

Fluconazoledrug

Administered orally