drugset
drugset / Trial / NCT03723395

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

NCT03723395 ↗

Phase 1 Completed 116 enrolled Seagen Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how the body breaks down tucatinib when there are lower levels of certain liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could change the levels of some liver and stomach enzymes in the body. This will help us know more about how tucatinib should be given to patients.

Timeline

Start
2018-09-17
Primary completion
2018-12-21
Completion
2018-12-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Digoxin Other / unclassified 0.5 mg —
Subject Gemfibrozil Small molecule 600 mg —
Subject Itraconazole Small molecule 200 mg —
Subject Midazolam Small molecule 2 mg —
Subject Repaglinide Small molecule 1 mg —
Subject Rifampin Small molecule 600 mg —
Subject Tolbutamide Small molecule 500 mg —
Subject Tucatinib Small molecule 300 mg Oral

Indications

No indication recorded.