Clinical trial NCT04733001: A Study to Investigate the Effect of Food on the Pharmacokinetics of HSG4112
Official title: A Randomized, Open-label, Single Dose, 3-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of HSG4112 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Glaceum
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
First posted: 2021-02-01
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. Study Objective: The objective of this clinical trial is to investigate the effect of food on the pharmacokinetics of HSG4112 after oral administration in healthy male subjects.
2. Study Design and Plan: This study is a randomized, open-label, single dose, 3-way crossover clinical trial. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. A total of 12 subjects will be randomized to 6 different sequence groups. Each subject will receive a single dose of HSG4112 480 mg via oral administration under fasted, low-fat diet, and high-fat diet conditions, with a washout period of 21 days in between each dosing.


Eligibility criteria: 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 26.9.

   ☞ 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 safety or pharmacokinetic 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. Smoked \> 10 cigarettes per day within 90 days prior to dosing.
11. Alcohol consumption of \> 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
12. 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.
13. 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.
14. 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.
15. Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.

Primary outcomes:
measure: Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
timeFrame: Hour 0 to 24
measure: Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
timeFrame: Hour 0 to 192
measure: Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112
timeFrame: Hour 0 to 192
Secondary outcomes:
measure: Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity
timeFrame: Hour 0 to 192
measure: Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
timeFrame: Hour 0 to 192
measure: Pharmacokinetic Assessment by Half-Life of HSG4112
timeFrame: Hour 0 to 192
measure: Pharmacokinetic Assessment by Oral Clearance of HSG4112
timeFrame: Hour 0 to 192
measure: Pharmacokinetic Assessment by Volume of Distribution of HSG4112
timeFrame: Hour 0 to 192
Other outcomes:
measure: Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
timeFrame: Up to 3 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram
timeFrame: Up to 3 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test
timeFrame: Up to 3 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
timeFrame: Up to 3 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Semen Volume
timeFrame: Up to 12 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Semen pH
timeFrame: Up to 12 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Semen White Blood Cells
timeFrame: Up to 12 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Sperm Count
timeFrame: Up to 12 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Sperm Motility
timeFrame: Up to 12 weeks from day of last dosing
measure: Safety and Tolerability Assessment by Number of Patients with Change in Sperm Morphology
timeFrame: Up to 12 weeks from day of last dosing
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: