A Phase 3 interventional study of MT-6548 and Iron supplement A in Healthy, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Other
The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.
Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Oral tablet
Also known as: vadadustat, AKB-6548
Oral tablet
Oral tablet
Oral tablet
Oral tablet
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)
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
Time frame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 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)
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)
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)
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)
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)
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| Started | 21 | 20 | 20 |
| Completed | 20 | 20 | 20 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| ug*h/mL | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 105.3 ± 17.0 | 100.2 ± 12.4 | 129.3 ± 18.1 |
| MT-6548+Iron supplement A | 49.2 ± 16.9 | — | — |
| MT-6548+Iron supplement B | 37.2 ± 19.5 | — | — |
| MT-6548+Iron supplement C | — | 47.7 ± 13.9 | — |
| MT-6548+Iron supplement D | — | — | 16.0 ± 10.7 |
| ug/mL | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 14.5 ± 2.61 | 15.5 ± 2.83 | 27.1 ± 5.93 |
| MT-6548+Iron supplement A | 7.76 ± 3.93 | — | — |
| MT-6548+Iron supplement B | 5.96 ± 3.09 | — | — |
| MT-6548+Iron supplement C | — | 9.37 ± 3.21 | — |
| MT-6548+Iron supplement D | — | — | 2.65 ± 1.95 |
| h | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 3.00 (1.50 to 5.00) | 1.00 (0.50 to 5.00) | 2.00 (1.00 to 3.00) |
| MT-6548+Iron supplement A | 3.00 (1.00 to 6.00) | — | — |
| MT-6548+Iron supplement B | 4.00 (1.00 to 5.00) | — | — |
| MT-6548+Iron supplement C | — | 1.00 (0.50 to 3.00) | — |
| MT-6548+Iron supplement D | — | — | 3.00 (0.50 to 5.00) |
| ug*h/mL | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 100.4 ± 16.1 | 96.3 ± 11.7 | 125 ± 17.2 |
| MT-6548+Iron supplement A | 47 ± 16.6 | — | — |
| MT-6548+Iron supplement B | 36 ± 19.1 | — | — |
| MT-6548+Iron supplement C | — | 46.4 ± 13.6 | — |
| MT-6548+Iron supplement D | — | — | 14.9 ± 10.4 |
| h | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 8.23 ± 0.95 | 6.97 ± 0.82 | 6.56 ± 1.05 |
| MT-6548+Iron supplement A | 8.06 ± 1.05 | — | — |
| MT-6548+Iron supplement B | 7.28 ± 0.98 | — | — |
| MT-6548+Iron supplement C | — | 5.76 ± 0.86 | — |
| MT-6548+Iron supplement D | — | — | 7.21 ± 1.47 |
| /h | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 0.1314 ± 0.0181 | 0.1356 ± 0.0216 | 0.1354 ± 0.0194 |
| MT-6548+Iron supplement A | 0.1302 ± 0.0146 | — | — |
| MT-6548+Iron supplement B | 0.1647 ± 0.0295 | — | — |
| MT-6548+Iron supplement C | — | 0.1629 ± 0.031 | — |
| MT-6548+Iron supplement D | — | — | 0.1518 ± 0.0499 |
| h | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| MT-6548 | 5.38 ± 0.8 | 5.22 ± 0.75 | 5.23 ± 0.83 |
| MT-6548+Iron supplement A | 5.39 ± 0.61 | — | — |
| MT-6548+Iron supplement B | 4.33 ± 0.71 | — | — |
| MT-6548+Iron supplement C | — | 4.4 ± 0.86 | — |
| MT-6548+Iron supplement D | — | — | 5.05 ± 1.63 |
Collected over Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/21 (0%) | 0/21 (0%) | 4/21 (19%) |
| Cohort 2 | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Cohort 3 | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| Abdominal discomfortGastrointestinal disorders | 3/21 | 0/20 | 0/20 |
| DiarrhoeaGastrointestinal disorders | 1/21 | 0/20 | 0/20 |
| Age, Categorical(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 20 | 20 | 61 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 21 | 20 | 20 | 61 |
| Race/Ethnicity, Customized(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Japanese | 21 | 20 | 20 | 61 |
| Other | 0 | 0 | 0 | 0 |
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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