At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Entrectinib Test Formulation (F1) +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 Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Entrectinib Test Formulation (F1) and Entrectinib Reference Formulation (F06) for Healthy Volunteers. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.
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 9, 2019
Primary CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 25 daysPosted 7.5 years ago
Interventions
Entrectinib Test Formulation (F1)drug
Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.
Entrectinib Reference Formulation (F06)drug
Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.