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

NCT06726863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2025-01-27
Completion
2025-02-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726863 on ClinicalTrials.gov