Effects of Iron Supplements on the Pharmacokinetics of MT-6548
Condition: Healthy
Intervention: MT-6548; Iron supplement A; Iron supplement B; Iron supplement C; Iron supplement D
Intervention description: Oral tablet; Oral tablet; Oral tablet; Oral tablet; Oral tablet
Intervention MeSH terms: Iron
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548
      co-administered with iron supplements in healthy male volunteers.
    

Eligibility criteria:

        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