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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a 4-treatment period study that uses three different models: Treatment Period 1 will be a single-arm model, Treatment Period 2 will be a parallel-group model, and Treatment Periods 3 and 4 will be crossover models.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment Period 1: Vamifeport IR Formulation Dose Level 1

Participants will receive multiple doses of Vamifeport Immediate-release (IR) formulation at Dose level 1.

Group Type EXPERIMENTAL

Vamifeport IRF

Intervention Type DRUG

Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.

Treatment Period 2: Vamifeport PR1 Dose Level 2

Participants will receive multiple doses of Vamifeport Prolonged-release formulation 1 (PR1) at Dose level 2.

Group Type EXPERIMENTAL

Vamifeport PR1

Intervention Type DRUG

Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Treatment Period 2: Vamifeport PR2 Dose Level 2

Participants will receive multiple doses of Vamifeport Prolonged-release formulation 2 (PR2) at Dose level 2.

Group Type EXPERIMENTAL

Vamifeport PR2

Intervention Type DRUG

Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Treatment Period 3: Vamifeport PR1 Dose Level 3

Participants will receive a single dose of Vamifeport PR1 at Dose level 3.

Group Type EXPERIMENTAL

Vamifeport PR1

Intervention Type DRUG

Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Treatment Period 3: Vamifeport PR2 Dose Level 3

Participants will receive a single dose of Vamifeport PR2 at Dose level 3.

Group Type EXPERIMENTAL

Vamifeport PR2

Intervention Type DRUG

Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Treatment Period 4: Vamifeport PR1 Dose Level 3

Participants will receive a single dose of Vamifeport PR1 at Dose level 3.

Group Type EXPERIMENTAL

Vamifeport PR1

Intervention Type DRUG

Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Treatment Period 4: Vamifeport PR2 Dose Level 3

Participants will receive a single dose of Vamifeport PR2 at Dose level 3.

Group Type EXPERIMENTAL

Vamifeport PR2

Intervention Type DRUG

Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Interventions

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Vamifeport IRF

Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.

Intervention Type DRUG

Vamifeport PR1

Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Intervention Type DRUG

Vamifeport PR2

Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Intervention Type DRUG

Other Intervention Names

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CSL624 CSL624 CSL624

Eligibility Criteria

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Inclusion Criteria

* Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 60 years when providing written informed consent.
* Healthy, as determined by the investigator based on review of defined assessments during Screening.
* Body weight between 50 and 100 kilograms (kg) (inclusive) and body mass index within the range 18.0 to 32.0 kg per meter squared (kg/m2) (inclusive) at Screening and Day -1.

Exclusion Criteria

* Any clinically relevant abnormal 12-lead ECG finding at Screening or Day -1 (as deemed by the investigator).
* Serum ferritin of \< 30 nanograms per milliliter (ng/mL) or \> 300 ng/mL for assigned male at birth (AMAB) subjects or \<16 ng/mL or \> 300 ng/mL for assigned female at birth (AFAB) subjects at Screening or Day -1.
* Hemoglobin \< 13 grams per deciliter (g/dL) (8.1 millimoles per liter \[mmol/L\]) for AMAB subjects or 12 g/dL (7.5 mmol/L) for AFAB subjects at Screening or Day -1.
* Blood draw or donation of blood (\>= 450 mL) within 3 months before Screening, plasma from 2 weeks before Screening, or platelets from 6 weeks before Screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes