At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
Entospletinibdrug
Likely dose
Entospletinib 100 mgfrom 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.
A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Entospletinib for Oncology. Completed, enrolled 56 participants across 6 sites in 3 countries.
Detailed Summary
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOncology
CountriesGermany, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartNov 2015
Primary CompletionOct 2017
TodayJul 2026
First PostedAug 13, 2015
Enrollment StartNov 16, 2015
Primary CompletionOct 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.9 years ago
Interventions
Entospletinibdrug
Entospletinib 100 mg tablet administered orally