Clinical Study to Investigate the Pharmacokinetics and Sa... | NCT05303961

NCT05303961

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SA001	Experimental	Part 1: 24 subjects are assigned to single dose groups(240mg, 480mg, 720mg, 1080mg of SA001) in a ratio of 1:1:1:1 and receiving each dose of SA001 in the period 1. Part2: 18 subjects are assinged to multiple dose groups(360mg, 720mg, 1080mg of SA001) in a ratio of 1:1:1 and receiving each dose of SA001.	Drug: SA001 240mg + Rebamipide 200mg or Placebo Drug: SA001 480mg or Placebo Drug: SA001 710mg + Rebamipide 600mg or Placebo Drug: SA001 1,080mg or Placebo Drug: SA001 360mg or Placebo Drug: SA001 720mg or Placebo
Rebamipide	Active Comparator	Part 1: 12 subjects are assigned to single dose groups(200mg, 600mg of Rebamipide) in a ratio of 1:1 and receiving each dose of Rebamipide in the period 2.	Drug: SA001 240mg + Rebamipide 200mg or Placebo Drug: SA001 710mg + Rebamipide 600mg or Placebo
Placebo	Placebo Comparator	Part 1: 8 subjects receiving a single dose of Placebo in the period 1. Part2: 6 subjects receiving multiple dose of Placebo.	Drug: SA001 240mg + Rebamipide 200mg or Placebo Drug: SA001 480mg or Placebo Drug: SA001 710mg + Rebamipide 600mg or Placebo Drug: SA001 1,080mg or Placebo Drug: SA001 360mg or Placebo Drug: SA001 720mg or Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SA001 240mg + Rebamipide 200mg or Placebo	Drug	Cohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo	Placebo Rebamipide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the Area Under the plasma concentration versus time Curve from the first observed to last(AUClast) of SA001 and Rebamipide	Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.	Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Measure the Area Under the plasma concentration versus time Curve from the first sampled data extrapolated to infinity(AUCinf) of SA001 and Rebamipide	Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.	Part 1: Predose9Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Measure the Peak Plasma Concentration (Cmax) of SA001 and Rebamipide	Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.	Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Measure the Time to peak drug concentration(Tmax) of SA001 and Rebamipide	Investigate the pharmacokinetic parameters by collecting blood and urine before and during administration of the investigational product.	Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Measure the Half Life(t1/2) of SA001 and Rebamipide	Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.	Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Event(AE)	Safety/Tolerability Assessment	Part 1: Day-1(before the administration) to approximately Day 24 (Post study Visit) / Part 2: Day-1(before the administration) to approximately Day 29 (Post study Visit)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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