Effects of Iron Supplements on the Pharmacokinetics of MT-6548

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: MT-6548; Drug: Iron supplement A; Drug: Iron supplement C; Drug: Iron supplement D; Drug: Iron supplement B

• Registration Number: NCT03645863
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Study Start: 2018-08-27
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Results First Submitted: 2021-03-15
• Results First Submitted QC: 2021-04-26
• Results First Posted: 2021-05-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	MT-6548	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.
Cohort 1	Iron supplement A	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.
Cohort 1	Iron supplement B	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.
Cohort 2	MT-6548	Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
Cohort 3	MT-6548	Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.
Cohort 2	Iron supplement C	Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
Cohort 3	Iron supplement D	Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.

Primary Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

Research site; 🇯🇵 Tokyo, Japan