Effects of Iron Supplements on the Pharmacokinetics of MT-6548

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03645863

Enrollment

Registered

2018-08-24

Start date

2018-08-27

Completion date

2018-09-30

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGMT-6548

Oral tablet

DRUGIron supplement A

Oral tablet

DRUGIron supplement B

Oral tablet

DRUGIron supplement C

Oral tablet

DRUGIron supplement D

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

Japan

Contacts

STUDY_DIRECTORGeneral Manager

Tanabe Pharma Corporation

Participant flow

Participants by arm

Arm	Count
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.	21
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.	20
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.	20
Total	61

Baseline characteristics

Characteristic	Cohort 1	Cohort 2	Cohort 3	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	21 Participants	20 Participants	20 Participants	61 Participants
Race/Ethnicity, Customized Japanese	21 Participants	20 Participants	20 Participants	61 Participants
Race/Ethnicity, Customized Other	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	21 Participants	20 Participants	20 Participants	61 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 20	0 / 20
other Total, other adverse events	4 / 21	0 / 20	0 / 20
serious Total, serious adverse events	0 / 21	0 / 20	0 / 20