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

Sponsor
CSL Behring
Study ID
NCT06726863
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 22, 2024
Status verified
Jun 2025
Primary completion
Jan 27, 2025
Completion
Feb 1, 2025

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Treatment Period 1: Vamifeport IR Formulation Dose Level 1
    Participants will receive multiple doses of Vamifeport Immediate-release (IR) formulation at Dose level 1.
  • Experimental: Treatment Period 2: Vamifeport PR1 Dose Level 2
    Participants will receive multiple doses of Vamifeport Prolonged-release formulation 1 (PR1) at Dose level 2.
  • Experimental: Treatment Period 2: Vamifeport PR2 Dose Level 2
    Participants will receive multiple doses of Vamifeport Prolonged-release formulation 2 (PR2) at Dose level 2.
  • Experimental: Treatment Period 3: Vamifeport PR1 Dose Level 3
    Participants will receive a single dose of Vamifeport PR1 at Dose level 3.
  • Experimental: Treatment Period 3: Vamifeport PR2 Dose Level 3
    Participants will receive a single dose of Vamifeport PR2 at Dose level 3.
  • Experimental: Treatment Period 4: Vamifeport PR1 Dose Level 3
    Participants will receive a single dose of Vamifeport PR1 at Dose level 3.
  • Experimental: Treatment Period 4: Vamifeport PR2 Dose Level 3
    Participants will receive a single dose of Vamifeport PR2 at Dose level 3.

Primary Outcome Measure

Plasma concentration-time course profiles of vamifeport [ Time Frame: Treatment Period (TP) 2: Before and after dosing on Day 4 (up to 12 hours), Day 8 (up to 48 hours), Before dosing on Day 5, 6, 7 TP 3: Before and after dosing on Day 13 (up to 48 hours) TP 4: Before and after dosing on Day 16 (up to 48 hours) ]

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