NCT06043739

Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects

A Randomized, Open-label, 3-period, Single-dose, Cross-over Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Filgotinib Given as an Oral Mini-tablet Formulation Versus the Oral Tablet Formulation of Filgotinib and to Assess the Effect of Food on the Oral Mini-tablet Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus oral tablet formulation and effect of food on the mini-tablet formulation.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	Filgotinib	Commercially developed film-coated tablet administered orally
DRUG	Filgotinib	Film-coated mini-tablets administered orally

Timeline

• Start date: 2023-09-22
• Primary completion: 2023-10-27
• Completion: 2023-11-12
• First posted: 2023-09-21
• Last updated: 2023-11-29

Locations

1 site across 1 country: Canada