Clinical trial NCT03645863: Effects of Iron Supplements on the Pharmacokinetics of MT-6548
Official title: A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 61
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
measure: Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
measure: Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
measure: Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
measure: Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
measure: Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
timeFrame: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Research site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
citation: 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.