At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Encorafenib capsule formulation (CAP) +3 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 PHASE 1, RANDOMIZED, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO ESTIMATE THE BIOAVAILABILITY OF TWO NEW ENCORAFENIB FORMULATIONS RELATIVE TO THE CURRENT FORMULATION AND TO EVALUATE THE EFFECT OF A PROTON-PUMP INHIBITOR ON ENCORAFENIB PLASMA PHARMACOKINETICS
In Brief
A Phase 1 clinical trial evaluating Encorafenib capsule formulation (CAP), Encorafenib first formulation, and 2 other interventions for Healthy. Completed, enrolled 18 participants across 1 site.
Detailed Summary
Relative bioavailability study to evaluate the pharmacokinetics of two new encorafenib formulations
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsOno Pharmaceutical Co., Ltd., Pierre Fabre Laboratories
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartJul 2022
First PostedJul 2022
Primary CompletionSep 2022
TodayJul 2026
First PostedJul 6, 2022
Enrollment StartJul 1, 2022
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.0 years ago
Interventions
Encorafenib capsule formulation (CAP)drug
A single encorafenib dose of the CAP formulation
Encorafenib first formulationdrug
first formulation
Encorafenib second formulationdrug
second formulation
Rabeprazole tabletdrug
Proton-pump inhibitor