A Study to Investigate the Effect of Food on the Pharmacokinetics of HSG4112

NCT04733001 | Completed Phase 1

• 1 other identifier: HSG4112-P1-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval

  Area under the plasma concentration-time curve of HSG4112 over dosing interval (AUCtau)

  Hour 0 to 24

• Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point

  Area under the plasma concentration-time curve from time zero to the last measurable point (AUClast)

  Hour 0 to 192

• Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112

  Maximum plasma concentration of HSG4112 (Cmax)

  Hour 0 to 192

Secondary Outcomes (5)

• Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity

  Hour 0 to 192

• Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112

  Hour 0 to 192

• Pharmacokinetic Assessment by Half-Life of HSG4112

  Hour 0 to 192

• Pharmacokinetic Assessment by Oral Clearance of HSG4112

  Hour 0 to 192

• Pharmacokinetic Assessment by Volume of Distribution of HSG4112

  Hour 0 to 192

Other Outcomes (10)

• Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs

  Up to 3 weeks from day of last dosing

• Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram

  Up to 3 weeks from day of last dosing

• Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test

  Up to 3 weeks from day of last dosing

Study Arms (3)

HSG4112 Treatment Arm: Fasted

EXPERIMENTAL

Single oral dosing of HSG4112 480 mg under fasted conditions

Drug: HSG4112

HSG4112 Treatment Arm: Low-Calorie Diet

EXPERIMENTAL

Single oral dosing of HSG4112 480 mg under low-calorie (400-500 kcal with 100-125 kcal fat) diet conditions

Drug: HSG4112

HSG4112 Treatment Arm: High-Calorie Diet

EXPERIMENTAL

Single oral dosing of HSG4112 480 mg under high-calorie (800-1000 kcal with 500-600 kcal fat) diet conditions

Drug: HSG4112

Interventions

HSG4112 DRUG

Once-daily oral administration

Also known as: 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol

HSG4112 Treatment Arm: Fasted; HSG4112 Treatment Arm: High-Calorie Diet; HSG4112 Treatment Arm: Low-Calorie Diet

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 26.9.
• ☞ 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.

You may not qualify if:

• 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 safety or pharmacokinetic 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.
• Smoked \> 10 cigarettes per day within 90 days prior to dosing.
• Alcohol consumption of \> 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
• 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.

Sponsors & Collaborators

• Glaceum: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 1, 2021
• Study Start: July 12, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)