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drugset / Trial / NCT06884072

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

NCT06884072 ↗

Phase 1 Active not recruiting 16 enrolled Abbisko Therapeutics Co, Ltd
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2025-04-08
Primary completion
2025-07-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimicotinib Small molecule 50 mg Oral

Indications

No indication recorded.