Iron pills and mystery drug: what happens inside healthy bodies?
NCT ID NCT03645863
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.
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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
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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
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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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