Status:
COMPLETED
Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers
Lead Sponsor:
Samjin Pharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
This study consists of Part 1 followed Part 2. Part 1 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and active compar...
Detailed Description
Part 1(Single dose, dose escalation study, SA001 240mg\~1,080mg dose group) The starting dose is SA001 240mg, and the maximum dose is 1,080mg. Each dose group is assigned to Experimental group (SA001...
Eligibility Criteria
Inclusion
- 19 years to 45 years (Healthy male Korean)
- Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m2
- Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study
Exclusion
- Subject with a disease history of any clinically significant condition as below.
- \- Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
- Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the study drug
- Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
- Serum ALT(SGPT)/AST(SGOT) \>1.5×institutional upper limit normal (ULN)
- eGFR\< 90mL/min/1.73m2
- Systolic blood pressure \<100 mmHg or \>160 mmHg
- Diastolic blood pressure \<60 mmHg or \>100 mmHg
- Inadequate cardiac function confirmed by 12-lead ECG findings at screening as followings:
- QTcF \> 430msec (males)
- PR interval \> 200msec or \< 110msec
- QRS complex \> 120msec
- Evidence of 2nd- or 3rd-degree atrioventricular (AV) block
- Pathologic Q waves (defined as Q-wave \> 40msec or depth \> 0.5mV)
- Evidence of ventricular preexicitation, left bundle branch block (LBBB), right bundle branch block (RBBB, Incomplete RBBB)
- Subject with risk factors for Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia, and arrhythmias
- Subject with a history of drug abuse within 60 days prior to screening or who is positive for drugs of abuse in urine tests at screening
- Subject who received any drugs such as
- Prescription drug or herbal medicine within 14 days prior to the first administration of the investigational products
- Over the counter (OTC) or vitamin within 7 days prior to the first administration of the investigational products
- Subject who received other investigational products within 90 days prior to the first administration of the investigational products
- Subject who have donated whole blood within 60 days prior to the first administration of the investigational products, or donated component blood or have received blood transfusion within 30 days prior to the first administration of the investigational products
- Subject who continuously drink alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol during the study period
- Subject with history of smoking within 90 days prior to the first administration of the investigational products
- Subject who cannot prohibit grapefruit/ caffeine-containing foods during the study period from 3 days before the first administration of the investigational products
- Man of reproductive potential not willing to use contraceptive measures during the study period
- Subject not eligible for study participation in the opinion of the investigator
Key Trial Info
Start Date :
June 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2016
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05303961
Start Date
June 7 2016
End Date
November 11 2016
Last Update
March 31 2022
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