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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0005208

Enrollment

Registered

2020-07-08

Start date

2020-07-12

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : HSG4112 480 mg will be administered to subjects under fasted, low-fat diet, or high-fat diet conditions according to their randomized group - Group 1: Fasting?Low Fat Diet?High Fat Diet - Gro

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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 8.36 ng/mL 5)Subjects with a systolic blood pressure of 150 mmHg, diastolic blood pressure of 100 mmHg after at least 3 minutes in sitting position

Design outcomes

Primary

Measure	Time frame
Cmax, AUC last of HSG4112	—

Secondary

Measure	Time frame
AUCinf, tmax, t1/2, CL/F, Vd/F of HSG4112	—

Countries

Korea, Republic of

Contacts

Public ContactSangmi Lee

Seoul National University Hospital

sangmi.lee903@gmail.com+82-2-2072-4081

Outcome results