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

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Vamifeport PR1; Drug: Vamifeport IRF; Drug: Vamifeport PR2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06726863

CSL624_1005

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 7 patient groups

Treatment Period 1: Vamifeport IR Formulation Dose Level 1

Experimental group

Description:

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

Treatment:

Drug: Vamifeport IRF

Treatment Period 2: Vamifeport PR1 Dose Level 2

Experimental group

Description:

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

Treatment:

Drug: Vamifeport PR1

Treatment Period 2: Vamifeport PR2 Dose Level 2

Experimental group

Description:

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

Treatment:

Drug: Vamifeport PR2

Treatment Period 3: Vamifeport PR1 Dose Level 3

Experimental group

Description:

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

Treatment:

Drug: Vamifeport PR1

Treatment Period 3: Vamifeport PR2 Dose Level 3

Experimental group

Description:

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

Treatment:

Drug: Vamifeport PR2

Treatment Period 4: Vamifeport PR1 Dose Level 3

Experimental group

Description:

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

Treatment:

Drug: Vamifeport PR1

Treatment Period 4: Vamifeport PR2 Dose Level 3

Experimental group

Description:

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

Treatment:

Drug: Vamifeport PR2