Effects of Iron Supplements on the Pharmacokinetics of MT-6548

NCT03645863 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MT-6548-J05
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (3)

Cohort 1

EXPERIMENTAL

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; Drug: Iron supplement A; Drug: Iron supplement B

Cohort 2

EXPERIMENTAL

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

Drug: MT-6548; Drug: Iron supplement C

Cohort 3

EXPERIMENTAL

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

Drug: MT-6548; Drug: Iron supplement D

Interventions

Iron supplement A DRUG

Oral tablet

Cohort 1

Iron supplement B DRUG

Oral tablet

Cohort 1

Iron supplement C DRUG

Oral tablet

Cohort 2

Iron supplement D DRUG

Oral tablet

Cohort 3

MT-6548 DRUG

Oral tablet

Also known as: vadadustat, AKB-6548

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Research site

Tokyo, Japan

Location

Related 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. doi: 10.1016/j.clinthera.2021.06.013. Epub 2021 Sep 10.

  PMID: 34511184 RESULT

MeSH Terms

Interventions

vadadustat

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

+81-3-5960-9608 Japanese only

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: August 27, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 7, 2026
• Results First Posted: May 18, 2021

Record last verified: 2025-12

Locations

JP (1)