The administration study of hematopoietic agents, antidiuretics, plasma substitutes and cortisol synthesis inhibitor in healthy adults

JRCT ID: jRCT1071230045

Registered date:25/07/2023

Basic Information

• Recruitment status: Complete

Health condition(s) or Problem(s) studied

Healthy adults
Sample collection for evaluating analysis and sampling methods for Anti-doping

• Date of first enrollment: 24/07/2023
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Blood sampling begins on the day following the subject's hospitalization and one of the Study Drug-1-Study Drug-12 (1 tablet of Evrenzo tablet 50 mg: roxadustat 50 mg, 1 tablet of Enaroy tablet 2 mg: enarodustat 2 mg, 1 tablet of Duvroq Tablet: daprodustat 2 mg, 1 tablet of MUSREDO tablet 25 mg: molidustat 25 mg, 1 tablet of VAFSEO tablet 300 mg: vadadustat 300 mg, 0.5 mL of NESP INJECTION PLASTIC SYRINGE: darbepoetin alfa 5microgramg, 0.5 mL of Darbepoetin alfa BS injection syringe: darbepoetin alfa 5 microgramg, 0.5 mL of Darbepoetin alfa BS injection syringe SANWA: darbepoetin alfa 5 microgramg, 0.5 mL of Darbepoetin Alfa BS Injection Syringe JCR: darbepoetin Alfa 5 microgramg, 1 tablet of MINIRINMELT OD Tablet 240 microgramg: desmopressin acetate hydrate 240 microgramg, 500 mL of VOLUVEN 6% solution: hydroxyethyl Starch 130000 30 g and 2 tablet of Isturisa Tablets 1mg: osilodrostat 2 mg) is administered to each subject. After that, blood and urine collection continue from the subjects based on the study protocol.

Outcome(s)

• Primary Outcome: Effects of sample collection method: Sample collection time, type and amount of sample collected
• Secondary Outcome: Detectable period of unchanged and metabolites of test drugs: Sample collection time, type and amount of sample collected

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 35age old
• Gender: Both

Include criteria

a. Age: 20 to 35 years (at the time when consent is given)
b. BMI at the time of prior examination :
Males 18.5 or more and less than 25.0, Female 17.6 more and less than 26.4
c. Individuals who the principal or subinvestigator believes to be acceptable for the study

Exclude criteria

a. Those who have a history of allergic symptoms due to drugs;
b. Those who are suspected of having an infectious disease, including SARS CoV 2 infection;
c. Those who are undergoing any therapy now or will undergo any therapy during the study period;
d. Those who were or are alcoholic, drug addicted, or depressed;
e. Those who have a history of or are suspected of having one of the following diseases;
Study Drug 1 to Study Drug 5:
Cerebral infarction, myocardial infarction, thromboembolism such as pulmonary embolism, cardiovascular disease, stroke, central hypothyroidism, hypertension, malignant tumor, proliferative diabetic retinopathy, macular edema, exudative age related macular degeneration, retinal vein occlusion and liver dysfunction
Study Drug 6 to Study Drug 9:
myocardial infarction, pulmonary infarction, cerebral infarction, hypertension and hyperkalemia
Study Drug 10:
Hyponatremia, habitual or psychogenic polydipsia, fluid retention requiring treatment with diuretics, syndrome of inappropriate secretion of antidiuretic hormone, renal dysfunction, cardiovascular disease with hypertension, severe disease, Arteriosclerosis, coronary artery thrombosis, angina pectoris, heart failure and anterior pituitary insufficiency
Study Drug 11:
Congenital long QT syndrome, congestive heart failure, bradyarrhythmia, hypokalemia, hypomagnesemia and other electrolyte abnormalities, hypertension, liver dysfunction, adrenal cortical dysfunction
Study Drug 12:
Pulmonary edema, congestive heart failure, renal dysfunction such as renal failure with oliguria or anuria, intracranial hemorrhage, hypernatremia, hyperchloremia, bleeding diathesis
f. Those who have a history of using ethical or over the counter drugs within five weeks ahead of administrating the study drug;
g. Those who have a history of consuming supplements, foods containing St. John's Wort, grapefruit, or its processed products within one week ahead of administrating the study drug
h. Those who have a history of treatment with other investigational or study drugs within 16 weeks before administration of the study drug or treatment with other investigational or study drugs containing approved ingredients within 12 weeks before administration of the study drug;
i. Those who have a history of having 200 mL or more of blood or 400 mL or more of blood sampled within 30 or 90 days before administrating the study drug, respectively, or a history of blood component transfusion within 14 days or whole blood transfusion within 90 days before administrating the study drug;
j. Those who weigh less than 50 kg for a male and less than 40 kg for a female at the time of preliminary

Related Information

• Primary Sponsor: Ikushima Ippei
• Secondary Sponsor: Okano Masato
• Source(s) of Monetary Support: Japan Anti-Doping Agency "JAPAN SPORT COUNCIL 2023 the Sports Promotion Fund"