Sponsor study identifier
interventional
61
1 country
1
Study Start
August 27, 2018
Actual (reported)Primary Completion
September 30, 2018
Actual (reported)Study Completion
September 30, 2018
Actual (reported)The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 22, 2018
Actual (reported)August 24, 2018
Actual (reported)August 27, 2018
Actual (reported)September 30, 2018
Actual (reported)September 30, 2018
Actual (reported)May 18, 2021
Actual (reported)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)
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.
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
Oral tablet
Research site
Tokyo, Japan
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.
General Manager
Tanabe Pharma Corporation
61 participants (actual enrollment reported by the registry).
First Submitted
August 22, 2018
First Posted
August 24, 2018
Study Start
August 27, 2018
Actual (reported)Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2018
Actual (reported)Study Completion
September 30, 2018
Actual (reported)Last Updated
April 6, 2026
Results First Posted
May 18, 2021
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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