A phase I clinical trial to investigate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after oral administration in healthy male subjects

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0003673
• Lead Sponsor: Glaceum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-15
• Last Update Posted: 2 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

1) Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
2) Males between 19 and 50 years of age at screening.
3) Body mass index (BMI) between 18 and 24.9.
? BMI (kg/m2) = Body weight (kg) / {Height (m)2}
4) 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 Criteria

1) 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).
2) 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.
3) Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice, aspirin, antibiotics).
4) 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
5) 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.
6) History of drug/chemical abuse or tested positive in urine drug screen.
7) 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.
8) 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).
9) 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.
10) Alcohol consumption of > 20 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
11) Smoked within 90 days prior to dosing. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
12) Smoker. However, participation is acceptable if the subject has quit smoking at least 3 months prior to dosing.
13) 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.
14) 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.
15) 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.
16) Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event Monitoring;Physical Examination, Vital Signs, 12-Lead Electrocardiogram, Clinical Laboratory Test;Semen Analysis;Maximum Plasma Concentration (Cmax), Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau), Area Under the Plasma Concentration-Time Curve from Time Zero to the Last Measurable Point (AUClast), Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf), Time to Maximum Observed Plasma Concentration (tmax), Half-life (t1/2), Oral Clearance (CL/F), Volume of Distribution (Vd/F);Maximum Plasma Concentration (Cmax), Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau), Area Under the Plasma Concentration-Time Curve from Time Zero to the Last Measurable Point (AUClast), Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf), Time to Maximum Observed Plasma Concentration (tmax), Half-life (t1/2), Oral Clearance (CL/F), Volume of Distribution (Vd/F)

Secondary Outcome Measures

Name	Time	Method
eptin, Adiponectin, Insulin, C-peptide, IL-6, TNF-a, CCL2