CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Drug Cocktail +1 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/NCT02993471
NCT02993471Phase 1Completed

Evaluation of the Effect of Ixekizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients With Moderate-to-Severe Plaque Psoriasis

Eli Lilly and Company·interventional·Posted Dec 15, 2016·Updated Mar 12, 2019

In Brief

A Phase 1 clinical trial evaluating Drug Cocktail and Ixekizumab for Psoriasis. Completed, enrolled 28 participants across 3 sites.

Detailed Summary

This study is known as a "drug interaction study." The purpose is to learn about how ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine, omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome P450. Each participant will complete two study periods. Participants will take the mixture of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about 17 weeks, including follow-up. Screening must be completed prior to study start.

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartDec 22, 2016
Primary CompletionNov 21, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.5 years ago

Interventions

Drug Cocktaildrug

Administered orally

Ixekizumabdrug

Administered SC