HealthyPhase 1NCT02470286

A Phase 1 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. at 1 site in South Korea.

Completed

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

Trial summary

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite 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: 40 participants
Where: 1 siteSouth Korea
Study dates: 29 Jun 2015to 30 Sep 2015
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/m^2
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/1.73m^2

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 prescription drug or herbal medicine within 14 days prior to the first administration of the Investigational product
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 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Phase1, Double-blind, Randomized, Placebo-control, Single Center, Single Dose Administration, Dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of SA001 in Healthy Male Volunteers.

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

Read the detailed description

This study consists of Part 1 followed Part 2.

Part 1 (Dose escalation study, SA001 60mg~300mg dose group) The part 1 is a dose escalation study. The starting dose is SA001 60mg, and the maximum dose is 300mg. 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 single oral administration on the fasting state.

Part 2 (Single dose and food effect study, SA001 120mg and 300mg dose group) The purpose of this part 2 is to evaluate the food effect of a high-fat diets(HFDs) on the single oral dose pharmacokinetics of SA001 and its metabolite.

Conditions: Healthy
Being tested: SA001 60mg or Placebo, SA001 120mg or Placebo, SA001 180mg or Placebo, SA001 240mg or Placebo, SA001 300mg or Placebo

What participants receive

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

SA001 60mg or PlaceboDrug
- Study Drug: SA001 60mg
- Comparator: Placebo
- Cohort 1 in the part 1 (Dose escalation study)
SA001 120mg or PlaceboDrug
- Study Drug: SA001 120mg
- Comparator: Placebo
- Cohort 2 in the part 1 (Dose escalation study) and part 2 (Food effect study)
SA001 180mg or PlaceboDrug
- Study Drug: SA001 180mg
- Comparator: Placebo
- Cohort 3 in the part 1 (Dose escalation study)
SA001 240mg or PlaceboDrug
- Study Drug: SA001 240mg
- Comparator: Placebo
- Cohort 4 in the part 1 (Dose escalation study)
SA001 300mg or PlaceboDrug
- Study Drug: SA001 300mg
- Comparator: Placebo
- Cohort 5 in the part 1(Dose escalation study) and part 2 (Food effect study)

Study groups in NCT02470286
Study group	Role	What they receive
Cohort 1 (SA001 60mg or Placebo)	Experimental	6 subjects receiving a single dose of 60mg SA001 and 2 subjects receiving placebo Receives: Drug: SA001 60mg or Placebo
Cohort 2 (SA001 120mg or Placebo)	Experimental	6 subjects receiving a single dose of 120mg SA001 and 2 subjects receiving placebo Receives: Drug: SA001 120mg or Placebo
Cohort 3 (SA001 180mg or Placebo)	Experimental	6 subjects receiving a single dose of 180mg SA001 and 2 subjects receiving placebo Receives: Drug: SA001 180mg or Placebo
Cohort 4 (SA001 240mg or Placebo)	Experimental	6 subjects receiving a single dose of 240mg SA001 and 2 subjects receiving placebo Receives: Drug: SA001 240mg or Placebo
Cohort 5 (SA001 300mg or Placebo)	Experimental	6 subjects receiving a single dose of 300mg SA001 and 2 subjects receiving placebo Receives: Drug: SA001 300mg or Placebo

What is being measured

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

The incidence of treated related adverse event
Safety/Tolerability Assessment in the part 1
Measured: Part1: Day-2(administration) to approximately Day 15 (Post study visit)

Secondary outcomes (9)

Area under the curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-∞) of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Maximum observed plasma concentration (Cmax) of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Time to reach the maximum observed plasma concentration (tmax) of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
t1/2 of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
CL/F of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Vz/F of SA001 and its metabolite
Measured: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
CLR of SA001 and its metabolite
CLR = Ae / AUCinf (Ae: total amount excreted in the urine)
Measured: Part1: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose, Part2: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose
Fraction recovered unchanged in urine (FR) of SA001 and its metabolite
Measured: Part1: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose, Part2: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose

Timeline

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

29 Jun 201530 Sep 2015

First posted12 Jun 2015 (estimated)
Study start29 Jun 2015
Primary completion18 Sep 2015
Study completion30 Sep 2015

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02470286
Sponsor's protocol ID: SJSA001
Status last verified: Mar 2022
First submitted: 1 Jun 2015
Last updated: 24 Mar 2022
Results posted: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase1, Double-blind, Randomized, Placebo-control, Single Center, Single Dose Administration, Dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of SA001 in Healthy Male Volunteers.
ClinicalTrials.gov ID: NCT02470286
Acronym / sponsor ID: SJSA001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Samjin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Jun 2015 (actual)
Primary completion: 18 Sep 2015 (actual)
Study completion: 30 Sep 2015 (actual)
First posted: 12 Jun 2015 (estimated)
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.

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

Detailed description

This study consists of Part 1 followed Part 2.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Cohort 1 (SA001 60mg or Placebo)	Experimental	Drug: SA001 60mg or Placebo6 subjects receiving a single dose of 60mg SA001 and 2 subjects receiving placebo
Cohort 2 (SA001 120mg or Placebo)	Experimental	Drug: SA001 120mg or Placebo6 subjects receiving a single dose of 120mg SA001 and 2 subjects receiving placebo
Cohort 3 (SA001 180mg or Placebo)	Experimental	Drug: SA001 180mg or Placebo6 subjects receiving a single dose of 180mg SA001 and 2 subjects receiving placebo
Cohort 4 (SA001 240mg or Placebo)	Experimental	Drug: SA001 240mg or Placebo6 subjects receiving a single dose of 240mg SA001 and 2 subjects receiving placebo
Cohort 5 (SA001 300mg or Placebo)	Experimental	Drug: SA001 300mg or Placebo6 subjects receiving a single dose of 300mg SA001 and 2 subjects receiving 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/m^2
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/1.73m^2

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 60mg or Placebo* Study Drug: SA001 60mg * Comparator: Placebo * Cohort 1 in the part 1 (Dose escalation study)	Drug	Cohort 1 (SA001 60mg or Placebo)
SA001 120mg or Placebo* Study Drug: SA001 120mg * Comparator: Placebo * Cohort 2 in the part 1 (Dose escalation study) and part 2 (Food effect study)	Drug	Cohort 2 (SA001 120mg or Placebo)
SA001 180mg or Placebo* Study Drug: SA001 180mg * Comparator: Placebo * Cohort 3 in the part 1 (Dose escalation study)	Drug	Cohort 3 (SA001 180mg or Placebo)
SA001 240mg or Placebo* Study Drug: SA001 240mg * Comparator: Placebo * Cohort 4 in the part 1 (Dose escalation study)	Drug	Cohort 4 (SA001 240mg or Placebo)
SA001 300mg or Placebo* Study Drug: SA001 300mg * Comparator: Placebo * Cohort 5 in the part 1(Dose escalation study) and part 2 (Food effect study)	Drug	Cohort 5 (SA001 300mg or Placebo)

Primary outcome

The incidence of treated related adverse event
Time frame: Part1: Day-2(administration) to approximately Day 15 (Post study visit)
Safety/Tolerability Assessment in the part 1

9 secondary outcomes

Area under the curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-∞) of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Maximum observed plasma concentration (Cmax) of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Time to reach the maximum observed plasma concentration (tmax) of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
t1/2 of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
CL/F of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
Vz/F of SA001 and its metabolite
Time frame: Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose
CLR of SA001 and its metabolite
Time frame: Part1: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose, Part2: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose
Fraction recovered unchanged in urine (FR) of SA001 and its metabolite
Time frame: Part1: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose, Part2: predose and 0 ~ 4, 4 ~ 8, 8 ~ 12, 12 ~ 24, 24 ~ 32 and 32 ~ 48 hours postdose

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 24 Mar 2022.

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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.

Kyung-sang Yu, M.D., Ph.D., M.B.A principal investigator

Seoul National University College of Medicine / Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.

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 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The incidence of treated related adverse event (time frame: Part1: Day-2(administration) to approximately Day 15 (Post study visit)). 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 NCT02470286.

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 24 Mar 2022.