HealthyPhase 1NCT05303961

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

A Phase 1 study of Healthy, run by Samjin Pharmaceutical Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: No sites listed yet
Study dates: 7 Jun 2016to 11 Nov 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 27Show fewer

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

About this study

Official title: A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of SA001 After Oral Administration in Healthy Male Subjects

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.

Conditions: Healthy
Being tested: SA001 240mg + Rebamipide 200mg or Placebo, SA001 480mg or Placebo, SA001 710mg + Rebamipide 600mg or Placebo, SA001 1,080mg or Placebo, SA001 360mg or Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SA001 240mg + Rebamipide 200mg or PlaceboDrug
Cohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo
SA001 480mg or PlaceboDrug
Cohort 2 in the Part1(Single dose): Study drug(SA001 480mg), Comparator(Placebo)
SA001 710mg + Rebamipide 600mg or PlaceboDrug
Cohort 3 in the Part1(Single dose): Study drug(SA001 720mg + Rebamipide 600mg), Comparator(Placebo)
SA001 1,080mg or PlaceboDrug
Cohort 4 in the Part1(Single dose): Study drug(SA001 1,080mg), Comparator(Placebo)
SA001 360mg or PlaceboDrug
Cohort 5 in the Part2(Multiple dose): Study drug(SA001 360mg), Comparator(Placebo)
SA001 720mg or PlaceboDrug
Cohort 6 in the Part2(Multiple dose): Study drug(SA001 720mg), Comparator(Placebo)
SA001 1,080mg or PlaceboDrug
Cohort 7 in the Part2(Multiple dose): Study drug(SA001 1,080mg), Comparator(Placebo)

Study groups in NCT05303961
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
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.
Measured: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
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.
Measured: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
Measure the Renal Clearance(CLr) of SA001 and Rebamipide
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measured: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
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.
Measured: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Measure the Half Life(t1/2) of SA001
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measured: 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)
Measure the Peak-trough Fluctuation (PTF) of SA001
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Measure the Renal Clearance(CLr) of SA001
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measured: 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
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201611 Nov 2016

First posted31 Mar 2022
Study start7 Jun 2016
Primary completion11 Nov 2016
Study completion11 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05303961
Sponsor's protocol ID: SJSA001_02
Status last verified: Mar 2022
First submitted: 22 Mar 2022
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of SA001 After Oral Administration in Healthy Male Subjects
ClinicalTrials.gov ID: NCT05303961
Acronym / sponsor ID: SJSA001_02
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Samjin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Jun 2016 (actual)
Primary completion: 11 Nov 2016 (actual)
Study completion: 11 Nov 2016 (actual)
First posted: 31 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Part 1(Single dose, dose escalation study, SA001 240mg~1,080mg dose group)

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SA001	Experimental	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 PlaceboPart 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.
Rebamipide	Active comparator	Drug: SA001 240mg + Rebamipide 200mg or Placebo, Drug: SA001 710mg + Rebamipide 600mg or PlaceboPart 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.
Placebo	Placebo comparator	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 PlaceboPart 1: 8 subjects receiving a single dose of Placebo in the period 1. Part2: 6 subjects receiving multiple dose of Placebo.

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (27 listed)

Subject with a disease history of any clinically significant condition as below.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SA001 240mg + Rebamipide 200mg or PlaceboCohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo	Drug	Placebo, Rebamipide, SA001
SA001 480mg or PlaceboCohort 2 in the Part1(Single dose): Study drug(SA001 480mg), Comparator(Placebo)	Drug	Placebo, SA001
SA001 710mg + Rebamipide 600mg or PlaceboCohort 3 in the Part1(Single dose): Study drug(SA001 720mg + Rebamipide 600mg), Comparator(Placebo)	Drug	Placebo, Rebamipide, SA001
SA001 1,080mg or PlaceboCohort 4 in the Part1(Single dose): Study drug(SA001 1,080mg), Comparator(Placebo)	Drug	Placebo, SA001
SA001 360mg or PlaceboCohort 5 in the Part2(Multiple dose): Study drug(SA001 360mg), Comparator(Placebo)	Drug	Placebo, SA001
SA001 720mg or PlaceboCohort 6 in the Part2(Multiple dose): Study drug(SA001 720mg), Comparator(Placebo)	Drug	Placebo, SA001
SA001 1,080mg or PlaceboCohort 7 in the Part2(Multiple dose): Study drug(SA001 1,080mg), Comparator(Placebo)	Drug	Placebo, SA001

Primary outcome

Measure the Area Under the plasma concentration versus time Curve from the first observed to last(AUClast) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Area Under the plasma concentration versus time Curve from the first sampled data extrapolated to infinity(AUCinf) of SA001 and Rebamipide
Time frame: Part 1: Predose9Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Peak Plasma Concentration (Cmax) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Time to peak drug concentration(Tmax) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Investigate the pharmacokinetic parameters by collecting blood and urine before and during administration of the investigational product.
Measure the Half Life(t1/2) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the apparent total body clearance(CL/F) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measure the apparent volume of distribution(Vz/F) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measure the Renal Clearance(CLr) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measure the cumulative fraction excreted unchanged parent in urine(Fe) of SA001 and Rebamipide
Time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0~48hours, Day 15 0~24hours)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measure the Trough Drug Concentration at steady state(Cmin,ss) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Peak Plasma Concentration at steady state(Cmax,ss) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the average drug concentration in plasma during a dosing interval at steady state(Cav,ss) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the area under the plasma concentration-time curve for dosing interval(AUCτ) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Time to peak drug concentration at steady state(Tmax,ss) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Half Life(t1/2) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Peak-trough Fluctuation (PTF) of SA001
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)
Investigate the pharmacokinetic parameters by collecting blood before and during administration of the investigational product.
Measure the Fraction recovered unchanged in urine (FR) of SA001
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)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measure the apparent total body clearance(CL/F) of SA001
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)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.
Measure the Renal Clearance(CLr) of SA001
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)
Investigate the pharmacokinetic parameters by collecting urine before and during administration of the investigational product.

1 secondary outcome

Incidence of Adverse Event(AE)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.

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Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, run by Samjin Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure the Area Under the plasma concentration versus time Curve from the first observed to last(AUClast) of SA001 and Rebamipide (time frame: Part 1: Predose(Day 1 0hour, Day 15 0hour), Postdose(Day 1 0.25~48hours, Day 15 0.25~48hours)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05303961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.