Effects of Iron Supplements on the Pharmacokinetics of MT-6548

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645863
• Other study ID #: MT-6548-J05
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MT-6548
Oral tablet
• Iron supplement A
Oral tablet
• Iron supplement B
Oral tablet
• Iron supplement C
Oral tablet
• Iron supplement D
Oral tablet

Locations

Country	Name	City	State
Japan	Research site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kokado Y, Kawai K, Nanjo T, Kinoshita S, Kondo K. In Vitro and Clinical Pharmacokinetic Studies of the Effects of Iron-containing Agents on Vadadustat, an Oral Hypoxia-inducible Factor-Prolyl Hydroxylase Inhibitor. Clin Ther. 2021 Aug;43(8):1408-1418.e5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-8) of Unchanged MT-6548		Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Primary	Maximum Plasma Concentration (Cmax) of Unchanged MT-6548		Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Primary	Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548		Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Primary	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)
Primary	Mean Residence Time From Zero to Infinity (MRT0-8) of Unchanged MT-6548		Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Primary	Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548		Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Primary	Terminal Elimination Half-life (t1/2) of Unchanged MT-6548		Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)