Effects of Iron Supplements on the Pharmacokinetics of MT-6548

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

Sponsors

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Source 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.

Overall Status Completed
Start Date 2018-08-27
Completion Date 2018-09-30
Primary Completion Date 2018-09-30
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure 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)
Enrollment 61
Condition
Intervention

Intervention Type: Drug

Intervention Name: MT-6548

Description: Oral tablet

Intervention Type: Drug

Intervention Name: Iron supplement A

Description: Oral tablet

Arm Group Label: Cohort 1

Intervention Type: Drug

Intervention Name: Iron supplement B

Description: Oral tablet

Arm Group Label: Cohort 1

Intervention Type: Drug

Intervention Name: Iron supplement C

Description: Oral tablet

Arm Group Label: Cohort 2

Intervention Type: Drug

Intervention Name: Iron supplement D

Description: Oral tablet

Arm Group Label: Cohort 3

Eligibility

Criteria:

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

Gender:

Male

Minimum Age:

20 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
General Manager Study Director Mitsubishi Tanabe Pharma Corporation
Location
Facility: Research site
Location Countries

Japan

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Cohort 1

Type: Experimental

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.

Label: Cohort 2

Type: Experimental

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

Label: Cohort 3

Type: Experimental

Description: Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: None (Open Label)

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