Clinical Trials/NCT04733001

NCT04733001

Completed

Phase 1

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

Glaceum1 site in 1 country12 target enrollmentJuly 12, 2020

ConditionsObesity

InterventionsHSG4112

DrugsHSG4112

Overview

Phase: Phase 1
Intervention: HSG4112
Conditions: Obesity
Sponsor: Glaceum
Enrollment: 12
Locations: 1
Primary Endpoint: Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.
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.

Registry

clinicaltrials.gov

Start Date

July 12, 2020

End Date

February 10, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Glaceum

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•☞ 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 Criteria

•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.

Arms & Interventions

HSG4112 Treatment Arm: Fasted

Single oral dosing of HSG4112 480 mg under fasted conditions

Intervention: HSG4112

HSG4112 Treatment Arm: Low-Calorie Diet

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

Intervention: HSG4112

HSG4112 Treatment Arm: High-Calorie Diet

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

Intervention: HSG4112

Outcomes

Primary Outcomes

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

Time Frame: Hour 0 to 24

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

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

Time Frame: Hour 0 to 192

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

Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112

Time Frame: Hour 0 to 192

Maximum plasma concentration of HSG4112 (Cmax)

Secondary Outcomes

Pharmacokinetic Assessment by Half-Life of HSG4112(Hour 0 to 192)
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 Oral Clearance of HSG4112(Hour 0 to 192)
Pharmacokinetic Assessment by Volume of Distribution of HSG4112(Hour 0 to 192)