臨床研究等提出・公開システム

Early Phase II, Randomized, Open-Label, Crossover, Single-Dose Study to evaluate the effect of GT-02037 subcutaneous formulation on blood levels of Growth Hormone and its Safety compared to Octreotide subcutaneous formulation in Japanese patients with Acromegaly

OUH02037

Wada Jun

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama

junwada@okayama-u.ac.jp

Uno Hideki

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama

+81-86-235-7515

unohideki@okayama-u.ac.jp

Not Recruiting

June. 22, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

treatment purpose

1. Japanese over 18 years old, at the time the informed consent was obtained
2. Patients with definite diagnosis of Acromegaly
3. Patients who give written consent with their free will prior to participation in this clinical trial

1. Patients who have undergone surgery to remove the pituitary gland tumor
2. Patients who have received radiation therapy for pituitary gland tumor
3. Patients receiving drug treatment with drugs that affect GH or the pituitary gland system (Somatostatin analogs, Dopamine agonists, GH antagonists, etc.), and the Investigator determines that these effects will remain at the time of study entry
4. Patients with a medical history of hypersensitivity to any of the components of the investigational drug in this study
5. Patients undergoing treatment for ongoing malignancies
6. Patients with serious systemic diseases (hepatic, renal, cardiovascular, endocrine, respiratory, etc.) or serious psychiatric diseases
7. Pregnant/possibly pregnant or lactating patients
8. HIV antigen/antibody, HBs antigen, or HCV antibody positive patients
9. Patients who have received any other investigational drug (including Post-marketing Clinical Trial drugs) within 12 weeks prior to the start of treatment with the investigational drug in this study
10. Patients with a history of alcohol or drug abuse within the past 12 months
11. Patients who are deemed unsuitable as subjects by the investigator

Both

Treatment-naive acromegaly due to pituitary adenoma in a Japanese patient

In the 1st period, a single subcutaneous injection of GT-02037 2.0 milligram or Octreotide 50 microgram.
In the 2nd period, a single subcutaneous injection of a different investigational drug from the 1st period.

Decreasing rate in blood GH level at the point of the largest decrease from the pre-administration value (Maximal reduction rate)

+81-86-235-7534

Mar. 16, 2022

No

none