Clinical Trial

A Study to Evaluate the Effect of a High-fat Meal on the Exposure of Pimicotinib Capsule in Healthy Subjects

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated April 20, 2025 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a study to evaluate the impact of a high - fat meal on the exposure of Pimicotinib capsules in healthy subjects. It is planned to recruit 16 healthy subjects and randomly and equally assign them to either Study Sequence A or Study Sequence B. Subjects in Sequence A will take a single 50 - milligram oral dose of Pimicotinib capsules in a post - high - fat - meal state during Phase 1. Subjects in Sequence B will take a single 50 - milligram oral dose of Pimicotinib capsules in a fasting state during Phase 1 and then receive cross - over administration in Phase 2. In total, blood samples will be collected at 34 time points for pharmacokinetic (PK) analysis.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-13.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-04-16
Trial Details
NCT Number NCT06884072
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Healthy Subjects
Enrollment 16 participants
Start Date 2025-04-08
Primary Completion 2025-07-01 (estimated)
Study Completion 2025-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-20