Effects of Iron Supplements on the Pharmacokinetics of MT-6548

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MT-6548
* Drug: Iron supplement A
* Drug: Iron supplement B
* Drug: Iron supplement C
* Drug: Iron supplement D


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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. | Drug: MT-6548<br>* Oral tablet<br>* Other names: AKB-6548;Drug: Iron supplement A<br>* Oral tablet<br>Drug: Iron supplement B<br>* Oral tablet<br>|
| Experimental: Cohort 2<br>Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4. | Drug: MT-6548<br>* Oral tablet<br>* Other names: AKB-6548;Drug: Iron supplement C<br>* Oral tablet<br>|
| Experimental: Cohort 3<br>Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4. | Drug: MT-6548<br>* Oral tablet<br>* Other names: AKB-6548;Drug: Iron supplement D<br>* Oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) | 
| Maximum Plasma Concentration (Cmax) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) | 
| Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) | 
| Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) | 
| Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) | 
| Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) | 
| Terminal Elimination Half-life (t1/2) of Unchanged MT-6548 |  | Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3) |