At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Selumetinib 50mg +1 moredrug
Likely dose
Selumetinib 50mgfrom 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.
An Open-label, Comparative Study to Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY-142886) (Hyd-Sulfate) Following Single Oral Dosing to Healthy Subjects and to Subjects With Mild, Moderate, and Severe Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Selumetinib 50mg and Selumetinib 25mg for Solid Tumors. Completed, enrolled 32 participants across 1 site.
Detailed Summary
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionNov 2014
TodayJul 2026
First PostedFeb 14, 2014
Enrollment StartMar 1, 2014
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.4 years ago
Interventions
Selumetinib 50mgdrug
HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
Selumetinib 25mgdrug
Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1