Effects of Iron Supplements on the Pharmacokinetics of MT... | NCT03645863

NCT03645863

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	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.	Drug: MT-6548 Drug: Iron supplement D

Name	Type	Description	Arm Group Labels	Other Names
MT-6548	Drug	Oral tablet	Cohort 1 Cohort 2 Cohort 3

Outcomes Module

Primary Outcomes

Measure	Description	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)

Eligibility Module

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

Name	Affiliation	Role
General Manager	Tanabe Pharma Corporation	Study Director

PubMed Identifier	Type	Citation	Retractions
34511184	Result	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.

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.
FG002	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Cohort 2

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548

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

Posted

Mean

Standard Deviation

ug*h/mL

Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)

ID	Title	Description
OG000	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.
OG001	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 20, 2018	Mar 12, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 10, 2018	Mar 12, 2021	SAP_001.pdf