Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adults

NCT06996184 | Completed Phase 1

• 1 other identifier: CSL624_1006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, single-center, randomized, open-label, single-dose, 2-way, 2-period, crossover study to evaluate the effect of food on the pharmacokinetics (PK) of vamifeport prolonged-release (PR) formulation in healthy adult participants. Participants will be randomly allocated to one of two treatment sequences.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport

  0-96 hours after dose

• AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport

  0-96 hours after dose

• Maximum observed plasma concentration (Cmax) of vamifeport

  0-96 hours after dose

Secondary Outcomes (14)

• Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport

  Up to Day 13 (+/- 2 days)

• Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport

  Up to Day 13 (+/- 2 days)

• Number of participants with clinically significant changes from baseline in clinical laboratory safety tests (biochemistry, hematology, and urinalysis), 12-lead electrocardiogram (ECG), and vital signs, reported as TEAEs

  Up to Day 13 (+/- 2 days)

• Percentage of participants with clinically significant changes from baseline in clinical laboratory safety tests (biochemistry, hematology, and urinalysis), 12-lead ECG, and vital signs, reported as TEAEs

  Up to Day 13 (+/- 2 days)

• Time of the maximum observed plasma concentration (Tmax) of vamifeport

  0-96 hours after dose

Study Arms (2)

Sequence 1: Vamifeport Fasted then Fed

EXPERIMENTAL

In sequence 1, eligible participants assigned to sequence 1 will receive a single vamifeport dose on an empty stomach on Day 1 (fasted condition), undergo a washout period, and then receive a single vamifeport dose after a standardized high-fat meal (fed condition) on Day 6.

Drug: Vamifeport (PR formulation)

Sequence 2: Vamifeport Fed then Fasted

EXPERIMENTAL

In sequence 2, eligible participants assigned to sequence 2 will receive a single vamifeport dose after a standardized high-fat meal on Day 1 (fed condition), undergo a washout period, and then receive a single vamifeport dose on an empty stomach (fasted condition) on Day 6.

Drug: Vamifeport (PR formulation)

Interventions

Vamifeport (PR formulation) DRUG

Vamifeport will be administered orally

Also known as: CSL624

Sequence 1: Vamifeport Fasted then Fed; Sequence 2: Vamifeport Fed then Fasted

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 60 years at the time of providing written informed consent.
• Healthy, as determined by the investigator based on review of defined assessments during Screening.
• Body weight between 50 and 100 kilogram (kg) (inclusive) and body mass index within the range 18.0 to 30.0 kg per square metre (kg/m2) (inclusive) at Screening and Day - 1.

You may not qualify if:

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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (1)

Investigator Site 82600083

Leeds, West Yorkshire, LS11 9E, United Kingdom

Location

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 27, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 4, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Locations

GB (1)