HealthyPhase 3NCT03645863

Effects of Iron Supplements on the Pharmacokinetics of MT-6548

A Phase 3 study testing MT-6548, Iron supplement A and Iron supplement B in people with Healthy, run by Tanabe Pharma Corporation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MT-6548, Iron supplement A and Iron supplement B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteJapan
Study dates: 27 Aug 2018to 30 Sep 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Research site
Tokyo

Other trials in Japan

About this study

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

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
Being tested: MT-6548, Iron supplement A, Iron supplement B, Iron supplement C, Iron supplement D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-6548Drug
Also called vadadustat, AKB-6548
Oral tablet
Iron supplement ADrug
Oral tablet
Iron supplement BDrug
Oral tablet
Iron supplement CDrug
Oral tablet
Iron supplement DDrug
Oral tablet

Study groups in NCT03645863
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: MT-6548; Drug: Iron supplement D

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
Measured: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
Measured: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
Measured: 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
Measured: 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
Measured: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
Measured: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
Measured: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 201830 Sep 2018

First posted24 Aug 2018
Study start27 Aug 2018
Primary completion30 Sep 2018
Study completion30 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645863
Sponsor's protocol ID: MT-6548-J05
Status last verified: Mar 2026
First submitted: 22 Aug 2018
Last updated: 6 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 34511184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03645863
Acronym / sponsor ID: MT-6548-J05
Conditions: Healthy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: 27 Aug 2018 (actual)
Primary completion: 30 Sep 2018 (actual)
Study completion: 30 Sep 2018 (actual)
First posted: 24 Aug 2018 (actual)
Results: Posted 18 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1	Experimental	Drug: MT-6548, Drug: Iron supplement A, Drug: Iron supplement BSubject 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.
Cohort 2	Experimental	Drug: MT-6548, Drug: Iron supplement CSubject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4.
Cohort 3	Experimental	Drug: MT-6548, Drug: Iron supplement DSubject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MT-6548Also: vadadustat, AKB-6548Oral tablet	Drug	Cohort 1, Cohort 2, Cohort 3
Iron supplement AOral tablet	Drug	Cohort 1
Iron supplement BOral tablet	Drug	Cohort 1
Iron supplement COral tablet	Drug	Cohort 2
Iron supplement DOral tablet	Drug	Cohort 3

Primary outcome

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)

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	21	20
Cohort 2	20	20
Cohort 3	20	20

Primary outcome: 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). Mean (Standard Deviation). Unit: ug*h/mL

Measure	Cohort 1 n = 21	Cohort 2 n = 20	Cohort 3 n = 20
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)

Population analysed: This analysis was performed only in subjects who have the data at each visit.

Primary outcome: Maximum Plasma Concentration (Cmax) of Unchanged MT-6548

Time frame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3). Mean (Standard Deviation). Unit: ug/mL

Measure	Cohort 1 n = 21	Cohort 2 n = 20	Cohort 3 n = 20
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)

Population analysed: This analysis was performed only in subjects who have the data at each visit.

Primary outcome: 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). Median (Full Range). Unit: h

Measure	Cohort 1 n = 21	Cohort 2 n = 20	Cohort 3 n = 20
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)

Population analysed: This analysis was performed only in subjects who have the data at each visit.

Primary outcome: 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 (Standard Deviation). Unit: ug*h/mL

Measure	Cohort 1 n = 21	Cohort 2 n = 20	Cohort 3 n = 20
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)

Population analysed: This analysis was performed only in subjects who have the data at each visit.

Adverse events

Time frame: Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 21 (0%)	4 of 21 (19%)	0 of 21
Cohort 2	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Cohort 3	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34511184Kokado 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

General Manager study director

Tanabe Pharma Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MT-6548, Iron supplement A and Iron supplement B in people with Healthy, run by Tanabe Pharma Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.