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Effects of Iron Supplements on the Pharmacokinetics of MT-6548

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645863
Recruitment Status : Completed
First Posted : August 24, 2018
Results First Posted : May 18, 2021
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MT-6548 Drug: Iron supplement A Drug: Iron supplement B Drug: Iron supplement C Drug: Iron supplement D Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: MT-6548
Oral tablet
Other Names:
  • vadadustat
  • AKB-6548

Drug: Iron supplement A
Oral tablet

Drug: Iron supplement B
Oral tablet
Experimental: Cohort 2
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
 Drug: MT-6548
Oral tablet
Other Names:
  • vadadustat
  • AKB-6548

Drug: Iron supplement C
Oral tablet
Experimental: Cohort 3
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.
 Drug: MT-6548
Oral tablet
Other Names:
  • vadadustat
  • AKB-6548

Drug: Iron supplement D
Oral tablet


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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645863


Locations
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Japan
Research site
Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
  Study Documents (Full-Text)

Documents provided by Mitsubishi Tanabe Pharma Corporation:
Study Protocol  [PDF] July 20, 2018
Statistical Analysis Plan  [PDF] December 10, 2018

More Information
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Publications of Results:

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03645863    
Other Study ID Numbers: MT-6548-J05
First Posted: August 24, 2018    Key Record Dates
Results First Posted: May 18, 2021
Last Update Posted: December 15, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Iron
Trace Elements
Micronutrients
Physiological Effects of Drugs