GastritisPhase 1NCT03509831
[KJ-INT-002] BE Study
A Phase 1 study testing INT-2150 and Irsogladine maleate 2 mg+Nizatidine 150 mg in people with Gastritis, run by Kukje Pharma at 1 site in South Korea.
Trial summary
Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects 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
- Gastritis
- What is being tested?
- INT-2150 and Irsogladine maleate 2 mg+Nizatidine 150 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2017to Apr 2018
- 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
- Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
- Body weight >= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m^2 (inclusive).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Who cannot join
- Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
- Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.
- Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.
- Alanine aminotransferase, alkaline phosphatase <=2x upper limit of normal (ULN) total bilirubin > 2.0mg/dl and eGRF <60mL/min/1.73m2
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males. One unit is equivalent to 10 gram of alcohol.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects
Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects
- Conditions
- Gastritis
- Being tested
- INT-2150, Irsogladine maleate 2 mg+Nizatidine 150 mg
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INT-2150Drug
- Period: INT-2150
- Period: Irsogladine maleate 2 mg+Nizatidine 150 mg
Irsogladine maleate 2 mg+Nizatidine 150 mgDrug
- Period: Irsogladine maleate 2 mg+Nizatidine 150 mg
- Period: INT-2150
| Study group | Role | What they receive |
|---|---|---|
| INT2150-A | Other | Not described Receives: Drug: INT-2150; Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg |
| INT2150-B | Other | Not described Receives: Drug: INT-2150; Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Pharmacokinetic Characteristics
Measured: One day
Cmax
Pharmacokinetic Characteristics
Measured: One day
Secondary outcomes (3)
AUC∞
Pharmacokinetic Characteristics
Measured: One day
tmax
Pharmacokinetic Characteristics
Measured: One day
t1/2
Pharmacokinetic Characteristics
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start2 Nov 2017
- Primary completion24 Jan 2018
- Study completionApr 2018 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kukje Pharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang-Heon Cho, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509831
- Sponsor's protocol ID
- KJ-INT-002
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT03509831
- Acronym / sponsor ID
- KJ-INT-002
- Conditions
- Gastritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Kukje PharmaUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 26 Apr 2018 (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.
Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INT2150-A | Other | Drug: INT-2150, Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg |
| INT2150-B | Other | Drug: INT-2150, Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
- Body weight >= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m^2 (inclusive).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Key exclusion criteria (7 listed)
- Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
- Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.
- Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.
- Alanine aminotransferase, alkaline phosphatase <=2x upper limit of normal (ULN) total bilirubin > 2.0mg/dl and eGRF <60mL/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 |
|---|---|---|
| INT-21501. Period: INT-2150 2. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg | Drug | INT2150-A, INT2150-B |
| Irsogladine maleate 2 mg+Nizatidine 150 mg1. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg 2. Period: INT-2150 | Drug | INT2150-A, INT2150-B |
Primary outcome
AUCt
Time frame: One day
Pharmacokinetic Characteristics
Cmax
Time frame: One day
Pharmacokinetic Characteristics
3 secondary outcomes
AUC∞
Time frame: One day
tmax
Time frame: One day
t1/2
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Gastritis
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
Active, not recruitingPhase 2
Vedolizumab for the Treatment of Collagenous Gastritis
Collagenous Gastritis
RecruitingObservational study
Family Members at INcreased-risk for Developing Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
RecruitingObservational study
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis
Gastric Cancer, Intestinal Metaplasia
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
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.
Sang-Heon Cho principal investigator
Inha 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 testing INT-2150 and Irsogladine maleate 2 mg+Nizatidine 150 mg in people with Gastritis, run by Kukje Pharma 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 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. 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?
Results are not available in the source record.
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?
AUCt (time frame: One day). 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 26 Apr 2018.