At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Alectinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Alectinib for Hepatic Impairment. Completed, enrolled 28 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesCzechia, Slovakia
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartDec 2015
Primary CompletionDec 2016
TodayJul 2026
First PostedDec 3, 2015
Enrollment StartDec 4, 2015
Primary CompletionDec 8, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.6 years ago
Interventions
Alectinibdrug
Participants will receive alectinib as per the dosage schedule mentioned in arm description.