NCT06694948

A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects

A Single-Center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules Under Fasting Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects 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

Interventions

Type	Name	Description
DRUG	pimicotinib capsules	pimicotinib capsules

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-01-03
• Completion: 2025-01-17
• First posted: 2024-11-19
• Last updated: 2025-02-17

Locations

1 site across 1 country: China