A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers

MT-6548-J05

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

2018-08-27

2018-09-30

2018-09-30

Completed

Early phase I

61

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}

2023-12-13