Phase 3
Completed N=61
Effects of Iron Supplements on the Pharmacokinetics of MT-6548
Healthy
Source: ClinicalTrials.gov NCT03645863 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548 — 105.3; 100.2; 129.3; 49.2 ug*h/mL
◆ Published Evidence
Emerging
10citations · ~2 / year
In Vitro and Clinical Pharmacokinetic Studies of the Effects of Iron-containing Agents on Vadadustat, an Oral Hypoxia-inducible Factor-Prolyl Hydroxylase Inhibitor.
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.
Linked Publications
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In Vitro and Clinical Pharmacokinetic Studies of the Effects of Iron-containing Agents on Vadadustat, an Oral Hypoxia-inducible Factor-Prolyl Hydroxylase Inhibitor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548 |
105.3; 100.2; 129.3; 49.2; 37.2; 47.7 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Unchanged MT-6548 |
14.5; 15.5; 27.1; 7.76; 5.96; 9.37 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548 |
3.00; 1.00; 2.00; 3.00; 4.00; 1.00 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548 |
100.4; 96.3; 125; 47; 36; 46.4 | — |
| PRIMARY Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548 |
8.23; 6.97; 6.56; 8.06; 7.28; 5.76 | — |
| PRIMARY Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548 |
0.1314; 0.1356; 0.1354; 0.1302; 0.1647; 0.1629 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of Unchanged MT-6548 |
5.38; 5.22; 5.23; 5.39; 4.33; 4.4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03645863) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.