NCT06779253

A Study to Investigate The Effect of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects

An Open-label, Fixed-Sequence Study to Investigate The Effect of Multiple Oral Doses of Pimicotinib on The Pharmacokinetics of Metformin, Fexofenadine and Rosuvastatin In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a an open-label, fixed-sequence DDI study conducted in Chinese healthy subjects to investigate the effect of multiple oral doses of pimicotinib on the pharmacokinetics of fexofenadine , rosuvastatin and metformin . Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration. Approximately 38 healthy subjects will be enrolled to achieve 28 evaluable healthy subjects complete the study. Blood samples will be collected for PK analysis .

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	pimicotinib capsules	the effect of multiple oral doses of pimicotinib (50 mg QD) on the pharmacokinetics of fexofenadine (P-gp sensitive substrate), rosuvastatin (BCRP sensitive substrate) and metformin (MATE1 sensitive substrate). Fexofenadine and rosuvastatin will be administered together as a cocktail, and metformin will be given via staggered dosing from the cocktail drugs administration

Timeline

• Start date: 2025-03-14
• Primary completion: 2025-04-04
• Completion: 2025-05-22
• First posted: 2025-01-16
• Last updated: 2025-06-26

Locations

1 site across 1 country: China