A Safety Study of Tucatinib in Healthy and Hepatically-Impaired Subjects

Phase 1 Completed 37 enrolled Seagen Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The investigators are doing this study to find out if tucatinib is safe for patients with liver problems. This study will look at participants with mild, moderate, and severe liver problems. For each participant with liver problems who takes part, a matching healthy participant who is of similar age, similar body mass index (BMI), and of the same sex will also take part. The study will look at how the drug affects healthy participants compared to participants with liver problems.

Timeline

Start: 2018-10-10
Primary completion: 2019-05-07
Completion: 2019-05-07

Publications

Topletz-Erickson AR, Lee AJ, Mayor JG, Sun H, Abdulrasool LI, Rustia EL, Walker LN, Endres CJ. The Pharmacokinetics and Safety of Tucatinib in Volunteers with Hepatic Impairment. Clin Pharmacokinet. 2022 Dec;61(12):1761-1770. doi: 10.1007/s40262-022-01183-6. Epub 2022 Dec 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tucatinib	Small molecule	300 mg	Oral

Indications

No indication recorded.