A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
研究概览
简要总结
The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1
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.
干预措施: MT-6548 (Drug)
Cohort 1
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.
干预措施: Iron supplement B (Drug)
Cohort 3
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.
干预措施: MT-6548 (Drug)
Cohort 2
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
干预措施: Iron supplement C (Drug)
Cohort 1
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.
干预措施: Iron supplement A (Drug)
Cohort 2
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
干预措施: MT-6548 (Drug)
Cohort 3
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.
干预措施: Iron supplement D (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
时间窗: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
时间窗: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
时间窗: 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
时间窗: 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
时间窗: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
时间窗: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
时间窗: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
次要结局
未报告次要终点