Effects of Iron Supplements on the Pharmacokinetics of MT-6548

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Drug: MT-6548

Drug: Iron supplement D

Drug: Iron supplement C

Drug: Iron supplement A

Drug: Iron supplement B

Study type

Interventional

Funder types

Industry

Identifiers

NCT03645863

MT-6548-J05

Details and patient eligibility

About

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

Enrollment

61 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

61 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Subject will receive MT-6548 on Day 1, 4, and 7. Subject will receive Iron supplement A on Day 1, 4, or 7. Subject will receive Iron supplement B on Day 1, 4, or 7.

Treatment:

Drug: Iron supplement B

Drug: Iron supplement A

Drug: MT-6548

Cohort 2

Experimental group

Description:

Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.

Treatment:

Drug: Iron supplement C

Drug: MT-6548

Cohort 3