NCT02621047

Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

The Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib: A Multiple-Center, Open-Label Study Following Single Oral Dosing of Alectinib to Subjects With Hepatic Impairment and Matched Healthy Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Alectinib	Participants will receive alectinib as per the dosage schedule mentioned in arm description.

Timeline

• Start date: 2015-12-04
• Primary completion: 2016-12-08
• Completion: 2016-12-08
• First posted: 2015-12-03
• Last updated: 2018-08-24
• Results posted: 2018-08-24

Locations

2 sites across 2 countries: Czechia, Slovakia