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CompletedNCT05303961Updated Mar 31, 2022

Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

A Phase 1 interventional study of SA001 240mg + Rebamipide 200mg or Placebo and SA001 480mg or Placebo in Healthy, sponsored by Samjin Pharmaceutical Co., Ltd.. Completed. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Samjin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Jun 2016, registered Mar 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study 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 comparator(Rebamipide) in healthy male volunteers.

Part 2 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of multiple oral dose of SA001 in healthy male volunteers.

Read the 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 or SA001 + Active Comparator(Rebamipide)) or Placebo group in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration.

Part 2 (Multiple dose, dose escalation study, SA001 360mg\~1,080mg dose group)

The starting dose is SA001 360mg, and the maximum dose is 1,080mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a multiple oral administration.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Samjin Pharmaceutical Co., Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 19 years to 45 years (Healthy male Korean)
  2. Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m2
  3. 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

Exclusion Criteria:

  1. 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.
  2. 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
  3. Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
  4. Serum ALT(SGPT)/AST(SGOT) >1.5×institutional upper limit normal (ULN)
  5. eGFR\< 90mL/min/1.73m2
  6. Systolic blood pressure \<100 mmHg or >160 mmHg
  7. Diastolic blood pressure \<60 mmHg or >100 mmHg

  8. 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)
  9. Subject with risk factors for Torsade de pointes such as long QT syndrome, family history of sudden death, heart failure, hypokalemia, and arrhythmias
  10. 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

  11. 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
  12. Subject who received other investigational products within 90 days prior to the first administration of the investigational products
  13. 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
  14. 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
  15. Subject with history of smoking within 90 days prior to the first administration of the investigational products
  16. Subject who cannot prohibit grapefruit/ caffeine-containing foods during the study period from 3 days before the first administration of the investigational products
  17. Man of reproductive potential not willing to use contraceptive measures during the study period
  18. Subject not eligible for study participation in the opinion of the investigator
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    SA001

    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

  • Active comparator
    Rebamipide

    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 comparator
    Placebo

    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

  • DrugSA001 240mg + Rebamipide 200mg or Placebo

    Cohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo

  • DrugSA001 480mg or Placebo

    Cohort 2 in the Part1(Single dose): Study drug(SA001 480mg), Comparator(Placebo)

  • DrugSA001 710mg + Rebamipide 600mg or Placebo

    Cohort 3 in the Part1(Single dose): Study drug(SA001 720mg + Rebamipide 600mg), Comparator(Placebo)

  • DrugSA001 1,080mg or Placebo

    Cohort 4 in the Part1(Single dose): Study drug(SA001 1,080mg), Comparator(Placebo)

  • DrugSA001 360mg or Placebo

    Cohort 5 in the Part2(Multiple dose): Study drug(SA001 360mg), Comparator(Placebo)

  • DrugSA001 720mg or Placebo

    Cohort 6 in the Part2(Multiple dose): Study drug(SA001 720mg), Comparator(Placebo)

  • DrugSA001 1,080mg or Placebo

    Cohort 7 in the Part2(Multiple dose): Study drug(SA001 1,080mg), Comparator(Placebo)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)

  2. 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.

    Time frame: Part 1: Predose9Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)

  3. 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.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)

  4. 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.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)

  5. 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.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)

  6. Measure the apparent total body clearance(CL/F) of SA001 and Rebamipide

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)

  7. Measure the apparent volume of distribution(Vz/F) of SA001 and Rebamipide

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)

  8. Measure the Renal Clearance(CLr) of SA001 and Rebamipide

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)

  9. Measure the cumulative fraction excreted unchanged parent in urine(Fe) of SA001 and Rebamipide

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)

  10. Measure the Trough Drug Concentration at steady state(Cmin,ss) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  11. Measure the Peak Plasma Concentration at steady state(Cmax,ss) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  12. Measure the average drug concentration in plasma during a dosing interval at steady state(Cav,ss) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  13. Measure the area under the plasma concentration-time curve for dosing interval(AUCτ) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  14. Measure the Time to peak drug concentration at steady state(Tmax,ss) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  15. Measure the Half Life(t1/2) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  16. Measure the Peak-trough Fluctuation (PTF) of SA001

    Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0, 12hour, Day 2 0hour, Day 5 0hour, Day 7 12hour, Day 8 0, 12hour), Postdose(Day 1 0.25~8hours, Day 8 0.25~8hours)

  17. Measure the Fraction recovered unchanged in urine (FR) of SA001

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0hour, Day 8 0hour, Day 16 0hour), Postdose(Day 1 0~24hours, Day 8 0~24hours, Day 16 0~24hours, Day 17 0~24hours)

  18. Measure the apparent total body clearance(CL/F) of SA001

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0hour, Day 8 0hour, Day 16 0hour), Postdose(Day 1 0~24hours, Day 8 0~24hours, Day 16 0~24hours, Day 17 0~24hours)

  19. Measure the Renal Clearance(CLr) of SA001

    Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

    Time frame: Part 2: Predose(Day 1 0hour, Day 8 0hour, Day 16 0hour), Postdose(Day 1 0~24hours, Day 8 0~24hours, Day 16 0~24hours, Day 17 0~24hours)

Secondary outcomes

  1. Incidence of Adverse Event(AE)

    Safety/Tolerability Assessment

    Time frame: 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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05303961
Lead sponsor
Samjin Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Jun 7, 2016
Primary completion
Nov 11, 2016
Completion
Nov 11, 2016
Last update
Mar 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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