NCT06726863

Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults

A Phase 1, Randomized, Open-label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Vamifeport After Multiple Oral Administration of One Immediate-release Formulation and After Single and Multiple Oral Administration of Two Prolonged-release Formulations in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, single-center, randomized, open-label study to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of vamifeport after multiple oral administrations of one immediate-release (IR) formulation and after single and multiple oral administrations of two prolonged-release (PR) formulation in healthy adult participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Vamifeport IRF	Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.
DRUG	Vamifeport PR1	Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.
DRUG	Vamifeport PR2	Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-01-27
• Completion: 2025-02-01
• First posted: 2024-12-10
• Last updated: 2025-06-27

Locations

1 site across 1 country: United Kingdom