At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Entrectinib Form A +1 moredrug
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.
A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Bioequivalence of Entrectinib Polymorph Forms A and C Under Fasted Conditions in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Entrectinib Form A and Entrectinib Form C for Healthy Volunteers. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study aims to demonstrate similarities between two different forms of entrectinib (A and C) when administered under fasted conditions in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartJan 2019
Primary CompletionFeb 2019
TodayJul 2026
First PostedJan 8, 2019
Enrollment StartJan 10, 2019
Primary CompletionFeb 6, 2019
TodayJul 2, 2026
Enrollment to primary: 26 daysPosted 7.5 years ago
Interventions
Entrectinib Form Adrug
Participants will receive a single oral dose of entrectinib form A under fasted conditions.
Entrectinib Form Cdrug
Participants will receive a single oral dose of entrectinib form C under fasted conditions.