The administration study of hematopoietic agents, diuretics and anabolic steroids in healthy adult males.

JRCT ID: jRCT1071240052

Registered date:22/08/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

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

• Date of first enrollment: 22/08/2024
• Target sample size: 18
• Study type: Interventional

Intervention(s)

The subject will be admitted to the hospital, and blood and urine collection will begin the next day. One of study drugs 1 to 6 will be assigned to the subject and administered.
Blood and urine collection will continue from the subject according to the study implementation plan.

Dosage and administration (number of doses: single dose)
Study drug-1: Intravenous administration, 0.5mL per tube (750IU as epoetin beta)
Study drug-2: Intravenous administration, 0.5mL per ampoule (750IU as epoetin alpha)
Study drug-3: Oral administration, 1 tablet (25mg as spironolactone)
Study drug-4: Intravenous administration, 1 ampoule (100mg as potassium canrenoate)

Dosage and administration (number of doses: 5 times, repeated once a day for 5 days)
Study drug-5: Topical administration, 0.3g (methyltestosterone 3mg/0.3g, testosterone propionate 1.5mg/0.3g)
Study drug-6: Oral administration, 3 tablets (methyltestosterone 3mg/3 tablets)

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 study drugs: Sample collection time, type and amount of sample collected

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 35age old
• Gender: Male

Include criteria

1) Age: 18 to 35 years (at the time when consent is given)
2) BMI at the time of prior examination :
Males 18.5 or more and less than 25.0
3) Individuals who the principal or subinvestigator believes to be acceptable for the study

Exclude criteria

1) Those who have experienced allergic symptoms due to drugs.
2) Those suspected of having an infectious disease, including the new coronavirus.
3) Those currently undergoing treatment for any disease or those who may undergo treatment during the study period.
4) Those who are alcoholic or drug dependent, or have a history of depression.
5) Those with a history of the following diseases or those suspected of having them
Study Drug-1 to Study Drug-2 :
Myocardial infarction, pulmonary infarction, cerebral infarction, and other thromboembolic diseases, hypertension, and hyperkalemia
Study Drug-3 to Study Drug-4 :
Renal dysfunction, hyperkalemia, Addison's disease, coronary arteriosclerosis, cerebral arteriosclerosis, liver dysfunction, convulsive predisposition such as epilepsy
Study Drug-5 to Study Drug-6 :
Androgen-dependent tumors, prostatic hyperplasia, heart disease, kidney disease, liver disease
6) Those who have used prescription drugs or over-the-counter drugs within 5 weeks of taking the study drug
7) Those who have used supplements, western medicine, or other drugs within 1 week of taking the test drug. Those who have consumed food containing St. John's wort, grapefruit, or processed products thereof.
8) Those who have received other investigational or study drugs within 16 weeks of the administration of the study drug, or those who have received investigational or study drugs containing approved ingredients within 12 weeks.
9) Those who have had 200mL or more of blood drawn or transfused within 30 days of the administration of the study drug, or 400mL or more within 90 days, or those who have donated blood components within 14 days.
10) Those who weigh less than 50kg at the time of the pre-examination, and those with Hb value of 16 or more and Ht value of 50% or more for study drug-1 to study drug-2.
11) Those whose urine collected during the pre-test was found to contain prohibited doping substances or substances that affect doping tests
12) Those who consume excessive amounts of alcohol on a daily basis, and those who do not agree to refrain from alcohol consumption during the test period
13) Those who are deemed inappropriate for participation in this study by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Higo Nozomi
• Source(s) of Monetary Support: Japan Anti-Doping Agency "JAPAN SPORT COUNCIL 2024 the Sports Promotion Fund"