Effects of Iron Supplements on the Pharmacokinetics of MT-6548

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2018-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Intervention Type DRUG

Oral tablet

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vadadustat AKB-6548

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes