Trial Outcomes & Findings for Effects of Iron Supplements on the Pharmacokinetics of MT-6548 (NCT NCT03645863)
NCT ID: NCT03645863
Last Updated: 2026-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Cohort 1
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Iron Supplements on the Pharmacokinetics of MT-6548
Baseline characteristics by cohort
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=37 Participants
|
20 Participants
n=56 Participants
|
20 Participants
n=95 Participants
|
61 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=37 Participants
|
20 Participants
n=56 Participants
|
20 Participants
n=95 Participants
|
61 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
21 Participants
n=37 Participants
|
20 Participants
n=56 Participants
|
20 Participants
n=95 Participants
|
61 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
MT-6548
|
105.3 ug*h/mL
Standard Deviation 17.0
|
100.2 ug*h/mL
Standard Deviation 12.4
|
129.3 ug*h/mL
Standard Deviation 18.1
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
MT-6548+Iron supplement A
|
49.2 ug*h/mL
Standard Deviation 16.9
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
MT-6548+Iron supplement B
|
37.2 ug*h/mL
Standard Deviation 19.5
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
47.7 ug*h/mL
Standard Deviation 13.9
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
16.0 ug*h/mL
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
MT-6548
|
14.5 ug/mL
Standard Deviation 2.61
|
15.5 ug/mL
Standard Deviation 2.83
|
27.1 ug/mL
Standard Deviation 5.93
|
|
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
MT-6548+Iron supplement A
|
7.76 ug/mL
Standard Deviation 3.93
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
MT-6548+Iron supplement B
|
5.96 ug/mL
Standard Deviation 3.09
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
9.37 ug/mL
Standard Deviation 3.21
|
—
|
|
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
2.65 ug/mL
Standard Deviation 1.95
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
MT-6548
|
3.00 h
Interval 1.5 to 5.0
|
1.00 h
Interval 0.5 to 5.0
|
2.00 h
Interval 1.0 to 3.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
MT-6548+Iron supplement A
|
3.00 h
Interval 1.0 to 6.0
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
MT-6548+Iron supplement B
|
4.00 h
Interval 1.0 to 5.0
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
1.00 h
Interval 0.5 to 3.0
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
3.00 h
Interval 0.5 to 5.0
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
MT-6548
|
100.4 ug*h/mL
Standard Deviation 16.1
|
96.3 ug*h/mL
Standard Deviation 11.7
|
125 ug*h/mL
Standard Deviation 17.2
|
|
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
MT-6548+Iron supplement A
|
47 ug*h/mL
Standard Deviation 16.6
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
MT-6548+Iron supplement B
|
36 ug*h/mL
Standard Deviation 19.1
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
46.4 ug*h/mL
Standard Deviation 13.6
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
14.9 ug*h/mL
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
MT-6548
|
8.23 h
Standard Deviation 0.95
|
6.97 h
Standard Deviation 0.82
|
6.56 h
Standard Deviation 1.05
|
|
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
MT-6548+Iron supplement A
|
8.06 h
Standard Deviation 1.05
|
—
|
—
|
|
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
MT-6548+Iron supplement B
|
7.28 h
Standard Deviation 0.98
|
—
|
—
|
|
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
5.76 h
Standard Deviation 0.86
|
—
|
|
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
7.21 h
Standard Deviation 1.47
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
MT-6548
|
0.1314 /h
Standard Deviation 0.0181
|
0.1356 /h
Standard Deviation 0.0216
|
0.1354 /h
Standard Deviation 0.0194
|
|
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
MT-6548+Iron supplement A
|
0.1302 /h
Standard Deviation 0.0146
|
—
|
—
|
|
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
MT-6548+Iron supplement B
|
0.1647 /h
Standard Deviation 0.0295
|
—
|
—
|
|
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
0.1629 /h
Standard Deviation 0.031
|
—
|
|
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
0.1518 /h
Standard Deviation 0.0499
|
PRIMARY outcome
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)Population: This analysis was performed only in subjects who have the data at each visit.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 Participants
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 Participants
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
MT-6548+Iron supplement A
|
5.39 h
Standard Deviation 0.61
|
—
|
—
|
|
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
MT-6548+Iron supplement B
|
4.33 h
Standard Deviation 0.71
|
—
|
—
|
|
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
MT-6548+Iron supplement C
|
—
|
4.4 h
Standard Deviation 0.86
|
—
|
|
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
MT-6548
|
5.38 h
Standard Deviation 0.8
|
5.22 h
Standard Deviation 0.75
|
5.23 h
Standard Deviation 0.83
|
|
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
MT-6548+Iron supplement D
|
—
|
—
|
5.05 h
Standard Deviation 1.63
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=21 participants at risk
Subject will receive oral MT-6548 tablet (150 mg) on Day 1, 4, and 7. Subject will receive Iron supplement A (Ferric Citrate Hydrate 250 mg) on Day 1, 4, or 7. Subject will receive Iron supplement B (Sodium Ferrous Citrate 50 mg) on Day 1, 4, or 7.
|
Cohort 2
n=20 participants at risk
Subject will receive oral MT-6548 tablet (150 mg) on Day 1 and 4. Subject will receive Iron supplement C (Sucroferric oxyhydroxide 500 mg) on Day 1 or 4.
|
Cohort 3
n=20 participants at risk
Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D (Dried Ferrous Sulfate 105 mg) on Day 1 or 4.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
3/21 • Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3)
|
0.00%
0/20 • Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3)
|
0.00%
0/20 • Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3)
|
0.00%
0/20 • Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3)
|
0.00%
0/20 • Day 1 to 10 (cohort 1), Day 1 to 7 (cohort 2 and 3)
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: +81-3-5960-9608 Japanese only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER