A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
NCT ID: NCT04732988
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2018-08-23
2021-05-24
Brief Summary
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2. Study Design and Plan: This study is a dose-block randomized, double-blind, placebo-controlled, single and multiple dosing, dose-escalation phase 1 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. Each subject will be randomized to one of the six groups for the single ascending dose (SAD) study or one of the three groups for the multiple ascending dose (MAD) study. Each dose group will consist of ten subjects, and among the ten subjects, eight subjects will be randomized to receive HSG4112 and two subjects will be randomized to receive placebo. The subjects will be studied in a double-blind manner and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration. The dosing duration for the MAD study is 14 days. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead electrocardiogram, laboratory test, semen analysis (MAD study only), physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HSG4112 30 mg Single Dose
Single oral dosing of HSG4112 30 mg
HSG4112
Once-daily oral administration
Placebo 30 mg Single Dose
Single oral dosing of Placebo 30 mg
Placebo
Once-daily oral administration
HSG4112 60 mg Single Dose
Single oral dosing of HSG4112 60 mg
HSG4112
Once-daily oral administration
Placebo 60 mg Single Dose
Single oral dosing of Placebo 60 mg
Placebo
Once-daily oral administration
HSG4112 120 mg Single Dose
Single oral dosing of HSG4112 120 mg
HSG4112
Once-daily oral administration
Placebo 120 mg Single Dose
Single oral dosing of Placebo 120 mg
Placebo
Once-daily oral administration
HSG4112 240 mg Single Dose (Fasted)
Single oral dosing of HSG4112 240 mg under fasted conditions
HSG4112
Once-daily oral administration
HSG4112 240 mg Single Dose (Fed)
Single oral dosing of HSG4112 240 mg under fed conditions
HSG4112
Once-daily oral administration
Placebo 240 mg Single Dose
Single oral dosing of Placebo 240 mg
Placebo
Once-daily oral administration
HSG4112 480 mg Single Dose
Single oral dosing of HSG4112 480 mg
HSG4112
Once-daily oral administration
Placebo 480 mg Single Dose
Single oral dosing of Placebo 480 mg
Placebo
Once-daily oral administration
HSG4112 720 mg Single Dose
Single oral dosing of HSG4112 720 mg
HSG4112
Once-daily oral administration
Placebo 720 mg Single Dose
Single oral dosing of Placebo 720 mg
Placebo
Once-daily oral administration
HSG4112 240 mg Multiple Dose
Once-daily multiple oral dosing of HSG4112 240 mg for 14 days
HSG4112
Once-daily oral administration
Placebo 240 mg Multiple Dose
Once-daily multiple oral dosing of Placebo 240 mg for 14 days
Placebo
Once-daily oral administration
HSG4112 480 mg Multiple Dose
Once-daily multiple oral dosing of HSG4112 480 mg for 14 days
HSG4112
Once-daily oral administration
Placebo 480 mg Multiple Dose
Once-daily multiple oral dosing of Placebo 480 mg for 14 days
Placebo
Once-daily oral administration
Interventions
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HSG4112
Once-daily oral administration
Placebo
Once-daily oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
50 Years
MALE
Yes
Sponsors
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Seoul National University Hospital
OTHER
Kyungpook National University Hospital
OTHER
Glaceum
INDUSTRY
Responsible Party
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Locations
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Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HSG4112-P1-01
Identifier Type: -
Identifier Source: org_study_id