NCT07210996

A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions in Healthy Subjects

A Single-center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions Under Fasting Conditions in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, two-treatment, single-dose, two-way crossover study to evaluate the relative bioavailability and tolerability of Pimicotinib capsules containing free base in different proportions in healthy participants. 20 healthy participants are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B.Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

Conditions

• Pharmacokinetics in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	pimicotinib capsules	pimicotinib capsules

Timeline

• Start date: 2025-09-12
• Primary completion: 2025-10-06
• Completion: 2025-10-16
• First posted: 2025-10-07
• Last updated: 2025-11-26

Locations

1 site across 1 country: China