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Iron pills and mystery drug: what happens inside healthy bodies?

NCT ID NCT03645863

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how iron supplements change the way the body handles a drug called MT-6548. It involved 61 healthy Japanese men and measured drug levels in the blood. The goal was to gather safety and drug interaction data, not to treat 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

61 people

The number who actually took part.

Started

Aug 2018

Finished

Sep 2018

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

20 to 45 years

Sex

Male participants only

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: * Parents and each grandparent of subjects are Japanese * Subjects judged as appropriate for this study by investigators based on the results of the tests at Screening, Day -1 and Day 1 Exclusion Criteria: * Subjects with signs of heart diseases on the result of screening test * Subjects with current conditions or histories of drug addiction or alcohol addiction * Subjects judged by investigators that they cannot comply with the prohibition during the confinement period * Subjects who have taken MT-6548 before * Subjects with current conditions or histories of drug or food allergies * Subjects with BMI below18.5 kg/m2, BMI above 25.0 kg/m2 or body weight below 50.0 kg at the screening test * Subjects who have undergone platelet or plasma donation 2 weeks prior to the consent * Subjects who have undergone blood donation or blood draw of 400 mL or above within 12 weeks prior to the consent, or 200 mL or above within 4 weeks prior to the consent * Subjects who have undergone blood donation or blood draw of 800 mL or above within one year prior to the consent * Subjects who have undergone surgical operations that can affect gastrointestinal absorption of medication (appendectomy and hernioplasty do not meet this exclusion criterion) * Subjects with positive results for HBs antigen, syphilis serum reaction, HCV antibody or HIV antigen / antibody at the screening test * Subjects who are unwilling to consent to use contraception from the beginning of study period to 90 days following the final dose of the study drug * Subjects who have participated in another clinical study and received study drugs within 12 weeks prior to consent, or within 5 times the half-life of the study drug (whichever is longer) * Subjects who have taken any medications except for the drug used for this clinical study within 7 days prior to the first dose of the study drug * Subjects who have had supplements within 7 days prior to the first dose of the study drug * Subjects who have had apples, citrus fruits such as grapefruits or any food products that contain apples or citrus fruits within 7 days prior to the first dose of the study drug * Subjects who have had food products which contain St John's Wort within 2 weeks prior to the first dose of the study drug

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Research site

    Tokyo, Japan

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