NCT06884072

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

A Phase 1, Open-label, Randomized, Single Dose, 2-Treatment, 2-Sequence, 2-Period Crossover Study to Evaluate the Effect of a High-fat Meal on the Exposures of Pimicotinib Capsule in Healthy Subjects

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Pimicotinib capsule	Pimicotinib capsule

Timeline

• Start date: 2025-04-08
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2025-03-19
• Last updated: 2025-04-20

Locations

1 site across 1 country: China