Determination of corticorelin and related peptides in plasma

JRCT ID: jRCTs031240311

Registered date:02/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 02/09/2024
• 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 will be discharged after completion of the entire scheduled schedule on the day following the administration of the study drug (3 days and 2 nights).
Corticorelin will be administered intravenously as a single dose. The dose is 100 microgram and CRH is injected intravenously gradually over approximately 30 seconds.

Outcome(s)

Primary Outcome

Plasma concentration of corticorelin
Measured in: Plasma CRH concentration

Secondary Outcome

Plasma concentration of peptides
Concentration of peptide hormones present endogenously, such as ACTH concentration to be measured

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) Weighing at least 50 kg and having a body mass index (BMI) of at least 18.5 and less than 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.

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 corticorelin
b) Subjects who require caution in the administration of corticorelin: those with a history of pituitary adenoma
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 prior to study drug administration or 400 mL (2 units) within 3 months.
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 pharmaceutical products or health foods containing St. John's Wort within 14 days prior to the administration of the research drug, or who has ingested food or drink (including foods containing grapefruit, oranges, or apples) and dietary supplements containing grapefruit, oranges, or apples within 7 days prior to the administration of the research drug and who is still unable to comply with the prohibition of ingestion during the study period.
i) Smoking or nicotine consumption 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) Other persons deemed inappropriate by the principal investigator or subinvestigator.

Related Information

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