Status:
COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
Lead Sponsor:
Glaceum
Collaborating Sponsors:
Seoul National University Hospital
Kyungpook National University Hospital
Conditions:
Obesity
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administ...
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
- Males between 19 and 50 years of age at screening.
- Body mass index (BMI) between 18 and 24.9.
- ☞ BMI (kg/m2) = Body weight (kg) / {Height (m)2}
- In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
Exclusion
- Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, or cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
- History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product.
- Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice, aspirin, antibiotics).
- One of more of the following laboratory test results at screening:
- ALT (SGPT) \> 60 IU/L
- Glucose (fasting) \> 110 mg/dL or \< 70 mg/dL
- Testosterone \<2.49 ng/mL or \> 8.36 ng/mL
- Systolic blood pressure of \< 90 mmHg or \> 150 mmHg, or diastolic blood pressure of \< 60 mmHg or \> 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.
- History of drug/chemical abuse or tested positive in urine drug screen.
- Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator.
- Participation in any clinical study or bioequivalence study involving administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
- Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
- Alcohol consumption of \> 20 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
- Smoked within 90 days prior to dosing. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
- Smoker. However, participation is acceptable if the subject has quit smoking at least 3 months prior to dosing.
- Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, or unable to abstain from ingesting such foods or beverages during the same period.
- Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
- Unable or unwilling to use acceptable contraceptive methods during the study period.
- ☞ Acceptable contraceptive methods include:
- Use of an intrauterine device, which has been proven highly effective, by the subject's spouse/partner.
- Physical contraception for subject or spouse/partner used with chemical sterilization.
- Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy) of the subject or the subject's spouse/partner.
- Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.
Key Trial Info
Start Date :
August 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04732988
Start Date
August 23 2018
End Date
May 24 2021
Last Update
November 1 2021
Active Locations (2)
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1
Kyungpook National University Hospital
Daegu, South Korea, 41944
2
Seoul National University Hospital
Seoul, South Korea, 03080