GastritisPhase 1NCT01762397
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
A Phase 1 study testing PMK-S005 in people with Gastritis and Gastric Ulcer, run by PharmaKing at 1 site in South Korea.
Trial summary
The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastritis, Gastric Ulcer
- What is being tested?
- PMK-S005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to May 2013
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male 20 year ≤ age ≤ 40 year.
- Weight ≥ 55kg, IBW ±20%.
- Patients with normal hematology, biochemistry, urinary result.
- Patients who have not congenital or chronic disease.
- Provision of written informed consent voluntarily.
Who cannot join
- Patients having known hypersensitivity to any component of the study drug.
- Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
- Patients with any gastrointestinal disorders.
- Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
- Drug abuser, alcoholic.
- Patients taking ETC medication within 14 days, OTC within 7 days.
- Patients taking other investigational product within 60 days prior to the participation in the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam national university hospital
Daejeon, Chungcheongnam-do, 301-721
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.
- Conditions
- Gastritis, Gastric Ulcer
- Being tested
- PMK-S005
- Medical subject headings
- Gastritis, Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMK-S005Drug
| Study group | Role | What they receive |
|---|---|---|
| PMK-S005 | Experimental | Not described Receives: Drug: PMK-S005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
- Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
- Before and after physical examination
- Before and after bital Sign: blood pressure, pulse rate, temperature.
- Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec.
- Lab: hematologic examination, blood coagulation examination,urine examination
Measured: 8day
Pharmacokinetics
- Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.
- Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
Measured: 8day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762397
- Sponsor's protocol ID
- PMK-S005
- Status last verified
- May 2014
- First submitted
- 20 Dec 2012
- Last updated
- 30 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01762397
- Acronym / sponsor ID
- PMK-S005
- Conditions
- Gastritis, Gastric Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- First posted
- 7 Jan 2013 (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 a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMK-S005 | Experimental | Drug: PMK-S005 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male 20 year ≤ age ≤ 40 year.
- Weight ≥ 55kg, IBW ±20%.
- Patients with normal hematology, biochemistry, urinary result.
- Patients who have not congenital or chronic disease.
- Provision of written informed consent voluntarily.
Key exclusion criteria (7 listed)
- Patients having known hypersensitivity to any component of the study drug.
- Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
- Patients with any gastrointestinal disorders.
- Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
- Drug abuser, alcoholic.
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 |
|---|---|---|
| PMK-S005 | Drug | PMK-S005 |
Primary outcome
Safety
Time frame: 8day
1. Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. 2. Before and after physical examination 3. Before and after bital Sign: blood pressure, pulse rate, temperature. 4. Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec. 5. Lab: hematologic examination, blood coagulation examination,urine examination
Pharmacokinetics
Time frame: 8day
1. Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2. 2. Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
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 30 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 testing PMK-S005 in people with Gastritis and Gastric Ulcer, run by PharmaKing 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 5 inclusion and 7 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 30 May 2014. 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?
Safety (time frame: 8day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2014.