A clinical trial to investigate the effect of food on the pharmacokinetics of HSG4112 in healthy male volunteers

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0005208
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-21
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1)Subjects who voluntarily agreed to participate in this study and singed the written informed consent form approved by the IRB, after fully listening to and understanding the details of this study before screening
2)Healthy adult male subjects aged 19 to 50 years at the time of screening
3)Subjects with a body mass index (BMI) within a range of 18.0 kg/m2 to 27.0 kg/m2
?BMI, kg/m2 = weight(kg)/[height(m)2]
4)Subjects in good health, determined by no clinically significant findings from medical history, physical examination, vital sign measurements, 12-lead ECG and clinical laboratory tests (Subjects with results that are not within the normal range may still participate with the approval of the Investigator)

Exclusion Criteria

1)Subjects with clinically significant history or manifestation of any hepatic, renal, nerve, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular, or psychiatric disorder (mood disorder, obsessive compulsive disorder, etc.)
2)Subjects with a history of any gastrointestinal disorder (e.g., Crohn’s disease, ulcer) or surgery (not including simple appendectomy, hemorrhoidectomy, and hernia surgery) which may affect the safety and pharmacokinetic assessment
3)Subjects with a history of clinically significant hypersensitivity to drugs including liquorice or other drugs (e.g., aspirin, antibiotics)
4)Subjects who showed one or more of the following clinical laboratory test results at screening:
-ALT (SGPT) > 60 IU/L
-Fasting glucose level > 110 mg/dL or <70 mg/dL
-Testosterone < 2.49 ng/mL or > 8.36 ng/mL
5)Subjects with a systolic blood pressure of < 90 mmHg or > 150 mmHg, diastolic blood pressure of < 60 mmHg or >100 mmHg after at least 3 minutes in sitting position

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Cmax, AUC last of HSG4112

Secondary Outcome Measures

Name	Time	Method
AUCinf, tmax, t1/2, CL/F, Vd/F of HSG4112