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

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

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Forty-two healthy adults, as follows, participated in this clinical study. 32 males: Age (mean) 22.3 years, Weight (mean) 63.8 kg, BMI (mean) 21.1 10 women: Age (mean) 26.2 years, Weight (mean) 53.2 kg, BMI (mean) 20.5 Participants met the selection criteria for each study drug group and had no history of disease or other exclusion criteria.

The 159 candidates (including pre-candidates) who agreed to participate in the study and were judged to be eligible based on the results of the pre-test were hospitalized two days before the study drug administration. 42 of them were admitted to the hospital to participate in the study, and the collection of samples (urine and blood) began on the day following their hospitalization, and 5 subjects each received study drug-1 to 5 (study drug-1 Everenzo tablet 50 mg, Study drug-2 Enalloy tablet 2mg, Study drug-3 Duvroq Tablet 2mg, Study drug-4 MUSREDO tablet 25mg, Study drug-5 Vadadustat tablet 300mg) in 5 cases each (3 males and 3 females), Study drug-6 to 9 (Study drug-6 NESP INJECTION PLASTIC SYRINGE, Study drug-7 Darbepoetin alfa BS injection sylinge, Study Drug-8 Darbepoetin alfa BS injection syringe SANWA, Study Drug-9 Darbepoetin alfa BS Injection syringe JCR) in 2 cases each and Study Drugs-10 to 12 (Study Drug-11 MINIRINMELT OD Tablet, Study Drug-11 VOLUVEN 6% solution, Study-12 Isturisa Tablets 1mg) were administered to 3 cases each, after which samples were continued to be collected and all study protocols were completed.

A minor adverse event occurred in one subject, but a causual relationship with the study drug was ruled out and the subject recovered during the study period.

Blood and urine samples were collected from subjects at the appropriate time, type, and volume to evaluate the influence of different sampling methods on analysis results.

Any one of the study drugs (study drug-1 Everenzo tablet 50 mg, Study drug-2 Enalloy tablet 2mg, Study drug-3 Duvroq Tablet 2mg, Study drug-4 MUSREDO tablet 25mg, Study drug-5 Vadadustat tablet 300mg, Study drug-6 NESP INJECTION PLASTIC SYRINGE, Study drug-7 Darbepoetin alfa BS injection sylinge, Study Drug-8 Darbepoetin alfa BS injection syringe SANWA, Study Drug-9 Darbepoetin alfa BS Injection syringe JCR, Study Drug-11 MINIRINMELT OD Tablet, Study Drug-11 VOLUVEN 6% solution, Study-12 Isturisa Tablets 1

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1071230045

Ikushima Ippei

Souseikai Sumida Hospital

1-29-1, Honjo, Sumida-ku, Tokyo 130-0004, Japan

ippei-ikushima@lta-med.com

Sato Mitsuhiko

LSI Medience Corporation

1-15-10 Shimura Itabashi-ku, Tokyo, Japan

+81-3-5994-2351

satou.mitsuhiko@ma.mediece.co.jp

Complete

July. 25, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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

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

Both

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

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.

Effects of sample collection method: Sample collection time, type and amount of sample collected

Detectable period of unchanged and metabolites of test drugs: Sample collection time, type and amount of sample collected

+81-92-283-7701

June. 21, 2023

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