At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 16 enrolled
Drug / intervention
Pexidartinibdrug
Likely dose
Pexidartinib 240 mLfrom 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, Single-dose Study to Assess the Pharmacokinetics of Pexidartinib in Subjects With Moderate Hepatic Impairment Compared to Healthy Subjects
In Brief
A Early Phase 1 clinical trial evaluating Pexidartinib for Moderate Hepatic Impairment. Completed, enrolled 16 participants across 2 sites.
Detailed Summary
The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate Hepatic Impairment
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedJan 2020
Primary CompletionOct 2020
TodayJul 2026
First PostedJan 10, 2020
Enrollment StartJan 7, 2020
Primary CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.5 years ago
Interventions
Pexidartinibdrug
Single, 200-mg capsule will be administered orally on Day 1 with 240 mL of water, following an overnight fast of at least 10 hours.