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Breakfast or not? study tests Food's impact on new drug formulation

NCT ID NCT06996184

Knowledge-focused Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial studied 28 healthy adults to see how food changes the absorption of a new prolonged-release version of vamifeport, an experimental drug. Participants took a single dose of the drug either with or without food, and researchers measured drug levels in the blood. The goal was to understand if food affects how the drug is processed, which will guide future dosing instructions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vamifeport (prolonged-release formulation)
What this could lead to
If successful, this could help determine the best way to take vamifeport (with or without food) for future studies in patients.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only looks at drug levels and safety, not whether the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

28 people

The number who actually took part.

Started

May 2025

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * •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. Exclusion Criteria: * •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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Investigator Site 82600083

    Leeds, West Yorkshire, LS11 9E, United Kingdom

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