Administration study of long-acting growth hormone preparations in healthy adults

JRCT ID: jRCT1001220001

Registered date:04/11/2022

Basic Information

• Recruitment status: Complete

Health condition(s) or Problem(s) studied

Healty adult subjects
Sample collection for evaluating analysis and sampling methods in antidoping

• Date of first enrollment: 22/09/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): The candidate subject is hospitalized and biological samples (urine / blood) collection are started the next day. The study drug (Sogroya Subcutaneous(Somapacitan) or Njenla Inj.(Somatrogon) or is injected on the second day of hospitalization. The samples will be continuously collected from the subject based on the test protocol.

Outcome(s)

• Primary Outcome: The evaluation on analysis method by examining the detectable period of the unchanged drug and the metabolite of the test drug
• Secondary Outcome: The confirmarion of the influence of the use of the test drug on biological marker variation

Key inclusion & exclusion criteria

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

Include criteria

1) Men BMI18.5 or more but less than 25.0 at the time of prior examination.
2) Women: BMI 17.6 or more and less than 26.4 at the time of prior examination.
Person who is judged by Principal investigator or Sub-investigator that there is no problem with participation in the test.

Exclude criteria

1) Subjects who have had allergic symptoms due to drugs
2) Subjects who are being treated for some disease or who may receive treatment during the study period
3) Those who are suspected of suffering from or have a history of the following diseases
Test drug-1
benign intracranial hypertension, hypoadrenocorticism, diabetes, diabetic complications, brain tumor,
Heart disease, renal dysfunction, liver dysfunction
Test drug-2
malignant tumor, hypothyroidism, hypoadrenocorticism, diabetes, brain tumor, heart disease,
renal dysfunction
4) Subjects who are alcoholic or drug dependent, or have a history of depression.
5) Subjects who used ethical drugs or over-the-counter drugs within 2 weeks of the scheduled administration of the study drug
6)Subjects who took supplements, foods containing St. John's wort, grapefruit, or processed products thereof within 1 week of scheduled administration of the study drug
7) Subjects who received another investigational drug or investigational drug within 16 weeks of the scheduled administration date of the investigational drug, or an investigational drug or investigational drug containing an approved ingredient within 12 weeks
8) Subjects who received 200 mL or more of blood within 30 days of the scheduled administration of the study drug, 400 mL or more of blood within 90 days, and those who received component blood donation within 14 days of the scheduled administration of the study drug.
9) Subjects weighing less than 40kg and 90kg or more at the time of pre-examination
10) Those who are suspected of having a new coronavirus infection
11) Lactating women, pregnant women, and those who may become pregnant during the study period
12) Subjects who are judged inappropriate for participation in this study by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Yonemura Takuma