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

StatusActive, Not Recruiting
PhasePhase 1
Started
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.

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 1, 2025 to Apr 8, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2025 to Apr 8, 2025
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06884072
Lead Sponsor Abbisko Therapeutics Co, Ltd
Conditions Healthy Subjects
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov