Investigation of biomarkers related to growth hormone administration

JRCT ID: jRCTs031230066

Registered date:09/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 09/05/2023
• Target sample size: 5
• Study type: Interventional

Intervention(s)

The patient will be admitted to the study institution the day before the administration of the study drug and discharged after all scheduled schedules are completed the day after the administration of the study drug (5 days and 4 nights).
Growth hormone will be administered subcutaneously in a single dose.
The dose shall be 0.25 mg/kg. However, the dose shall not exceed 15 mg.

Outcome(s)

• Primary Outcome: Time variation of peak area of plasma peptides
• Secondary Outcome: Plasma concentrations of somatologon and growth hormones (GH22 and GH20) and their time trends

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

Healthy adult male volunteers who have consented to the consent acquisition and who meet all of the following criteria will be included in the study.

a) Healthy adult male volunteers between the ages of 20 and 40 years at the time of consent.
b) Weigh 50 kg or more and have a Body Mass Index (BMI) of 18.5 to 25.0 at the time of screening.
c) Subjects who are deemed suitable by the principal investigator or a research associate based on their medical history and physical and clinical examination at the time of screening.
d) Subjects must be able to understand and comply with the research protocol and give their free and voluntary written consent.

Rationale for the Selection Criteria
a), b) : The selection criteria were established because the pharmacokinetic study will be conducted on standard subjects. c) The selection criteria were established because of safety considerations.
c) : For safety considerations.
d) : For ethical considerations.

Exclude criteria

Subjects who meet any of the following criteria will not be included in this study

a) Subjects with a history of hypersensitivity to growth hormone
b) Subjects for whom growth hormone administration is contraindicated: diabetics, subjects with malignant tumors
c) Hypotension (systolic blood pressure < 90 mmHg) or hypertension (systolic blood pressure > 160 mmHg) at screening.
d) Donated or lost more than 200 mL (1 unit) of blood within 4 weeks or 400 mL (2 units) within 3 months prior to administration of the study drug.
e) Who has a history/complications of significant neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, gastrointestinal (including gastrointestinal diseases that are judged to affect absorption of the research drug), respiratory, or metabolic diseases.
f) Who have clinically significant abnormalities identified by the Principal Investigator or a Research Assigning Physician on medical examination or physical examination.
g) Has a clinically significant illness within 30 days prior to administration of the study drug.
h) Who has ingested any pharmaceutical product or any health food containing St. John's Wort within 14 days prior to the start of the study, or any food or drink (including food containing grapefruit, oranges, or apples) and any dietary supplement within 7 days prior to the start of the study, and who is unable to comply with the prohibition of consumption even during the study period.
i) Who have smoked or consumed nicotine within 30 days prior to the administration of the study drug and who are unable to comply with the smoking ban during the study period.
j) Consumed alcohol or caffeine-containing substances on the day prior to admission and is unable to comply with the prohibition of consumption by the day of discharge.
k) Have a positive breath alcohol test or urine drug test at the time of screening.
l) The patient is unable to discontinue the use of any medication other than the study drug from 2 weeks prior to administration of the study drug until the end of the study.
m) Persons who test positive for Hepatitis B surface (HBs) antigen, hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody.
n) Persons who are judged by the principal investigator to have an underactive thyroid based on theresults of thyroid function tests at screening.
o) Other persons who are judged to be inappropriate by the principal investigator or subinvestigator.

Rationale for Exclusion Criteria
The exclusion criteria were established in order to properly assess the safety and efficacy of the study drug.
a), b), c), d), e), f), g),n) : Established to ensure the safety of subjects.
h), i), j) : Established due to possible pharmacokinetic effects.
k), l), o) : Established to exclude the participation of persons who are likely to be unable to complete the study.
m) : To prevent transmission of infection to the staff of the institution where the study was conducted and to the person in charge of the measurement.

Related Information

• Primary Sponsor: Furihata Kenichi
• Source(s) of Monetary Support: Japan Anti-Doping Agency(JADA)