Skip to main content
OpenTrials
Completed

NCT Number: NCT03645863

Effects of Iron Supplements on the Pharmacokinetics of MT-6548

The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-6548

Drug

Oral tablet

Other names: vadadustat, AKB-6548

Iron supplement A

Drug

Oral tablet

Iron supplement B

Drug

Oral tablet

Iron supplement C

Drug

Oral tablet

Iron supplement D

Drug

Oral tablet

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2018
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.