Effects of Iron Supplements on the Pharmacokinetics of MT-6548

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Iron

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