NCT03758339

A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [¹⁴C]-Tucatinib Following a Single Oral Dose in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cascadian Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib while it is still in the body. Healthy participants will get one dose of tucatinib by mouth. Patients will be monitored for 8-14 days after they take the dose of tucatinib.

Detailed description

This study will examine the absorption, metabolism, and excretion of tucatinib in healthy individuals. Participants will receive one oral dose of tucatinib and will be followed for 8-14 days after the dose is received.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	tucatinib	Single dose of 300 mg of \[¹⁴C\]-tucatinib containing approximately 150 μCi of \[¹⁴C\] radioactivity

Timeline

• Start date: 2017-12-30
• Primary completion: 2018-01-30
• Completion: 2018-01-30
• First posted: 2018-11-29
• Last updated: 2018-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study