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drugset / Trial / NCT02993471

A Study of Ixekizumab in Participants With Plaque Psoriasis

NCT02993471 ↗

Phase 1 Completed 28 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2016-12-22
Primary completion
2017-11-21
Completion
2017-11-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule — Oral
Subject Dextromethorphan Unknown — Oral
Subject Ixekizumab Monoclonal antibody — Subcutaneous
Subject Midazolam Small molecule — Oral
Subject Omeprazole Other / unclassified — Oral
Subject Vitamin K Unknown — Oral
Subject Warfarin Small molecule — Oral

Indications

psoriasis