drugset / Trial / NCT03556592

Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4

NCT03556592

Phase 1 Completed 40 enrolled LEO Pharma
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: * 14 weeks of treatment with tralokinumab * a single dose of tralokinumab

Timeline

Start
2018-08-13
Primary completion
2020-03-16
Completion
2020-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 100 mg Oral
Subject Metoprolol Other / unclassified 100 mg Oral
Subject Midazolam Small molecule 2 mg Oral
Subject Omeprazole Other / unclassified 20 mg Oral
Subject Tralokinumab Monoclonal antibody Subcutaneous
Subject Warfarin Small molecule 10 mg Oral

Indications