Anti-Ulcer AgentsPhase 1NCT03383042
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
A Phase 1 study testing Cohort 1 (JP-1366 A mg), Cohort 2 (JP-1366 B mg) and Cohort 3 (JP-1366 C mg) in people with Anti-Ulcer Agents, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anti-Ulcer Agents
- What is being tested?
- Cohort 1 (JP-1366 A mg), Cohort 2 (JP-1366 B mg) and Cohort 3 (JP-1366 C mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2017to 5 Apr 2019
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males aged between 19 and 50 at screening
- Weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Who cannot join
- Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Subject has been Helicobacter pylori positive
- AST (SGOT) and ALT (SGPT) > 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Subject has anatomical disability in insertion and maintenance of pH meter catheter
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital(SNUH)
Seoul, Jongno-Gu, 110-744
About this study
Official title: A Randomized, Open-label, Placebo- and Active- Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects
- Conditions
- Anti-Ulcer Agents
- Being tested
- Cohort 1 (JP-1366 A mg), Cohort 2 (JP-1366 B mg), Cohort 3 (JP-1366 C mg), Cohort 4 (JP-1366 D mg), Cohort 5 (JP-1366 E mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 (JP-1366 A mg)Drug
Also called SAD
Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 2 (JP-1366 B mg)Drug
Also called SAD
Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 3 (JP-1366 C mg)Drug
Also called SAD
Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 4 (JP-1366 D mg)Drug
Also called SAD
Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 5 (JP-1366 E mg)Drug
Also called SAD
Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 6 (JP-1366 F mg)Drug
Also called MAD
Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 7 (JP-1366 G mg)Drug
Also called MAD
Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 8 (JP-1366 H mg)Drug
Also called MAD
Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg
Cohort 9 (JP-1366 I mg)Drug
Also called MAD
Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single-ascending cohort 1 Receives: Drug: Cohort 1 (JP-1366 A mg) |
| Cohort 2 | Experimental | Single-ascending cohort 2 Receives: Drug: Cohort 2 (JP-1366 B mg) |
| Cohort 3 | Experimental | Single-ascending cohort 3 Receives: Drug: Cohort 3 (JP-1366 C mg) |
| Cohort 4 | Experimental | Single-ascending cohort 4 Receives: Drug: Cohort 4 (JP-1366 D mg) |
| Cohort 5 | Experimental | Single-ascending cohort 5 Receives: Drug: Cohort 5 (JP-1366 E mg) |
| Cohort 6 | Experimental | Multiple-ascending cohort 1 Receives: Drug: Cohort 6 (JP-1366 F mg) |
| Cohort 7 | Experimental | Multiple-ascending cohort 2 Receives: Drug: Cohort 7 (JP-1366 G mg) |
| Cohort 8 | Experimental | Multiple-ascending cohort 3 Receives: Drug: Cohort 8 (JP-1366 H mg) |
| Cohort 9 | Experimental | Multiple-ascending cohort 4 Receives: Drug: Cohort 9 (JP-1366 I mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
SAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
AUClast
SAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
AUCinf
SAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
tmax
SAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
t1/2
SAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Cmax,ss
MAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
Cmin,ss
MAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
Cav,ss
MAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
AUCτ
MAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
tmax,ss
MAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
t1/2
MAD endpoint
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
Percentage of total time that the intragastric pH was above 4
SAD
Measured: 0-24 hours(Day -1), 0-24 hours(Day 1)
Percentage of total time that the intragastric pH was above 4
MAD
Measured: 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7)
Serum gastrin concentration
SAD
Measured: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose
Serum gastrin concentration
MAD
Measured: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24h post-dose, Day 4 pre-dose, Day 6 pre-dose, Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start22 Dec 2017
- Primary completion23 Nov 2018
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Ulcer AgentsStudies 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
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383042
- Sponsor's protocol ID
- JP-1366-101-FIH
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Placebo- and Active- Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03383042
- Acronym / sponsor ID
- JP-1366-101-FIH
- Conditions
- Anti-Ulcer Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 26 Dec 2017 (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.
Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Cohort 1 (JP-1366 A mg)Single-ascending cohort 1 |
| Cohort 2 | Experimental | Drug: Cohort 2 (JP-1366 B mg)Single-ascending cohort 2 |
| Cohort 3 | Experimental | Drug: Cohort 3 (JP-1366 C mg)Single-ascending cohort 3 |
| Cohort 4 | Experimental | Drug: Cohort 4 (JP-1366 D mg)Single-ascending cohort 4 |
| Cohort 5 | Experimental | Drug: Cohort 5 (JP-1366 E mg)Single-ascending cohort 5 |
| Cohort 6 | Experimental | Drug: Cohort 6 (JP-1366 F mg)Multiple-ascending cohort 1 |
| Cohort 7 | Experimental | Drug: Cohort 7 (JP-1366 G mg)Multiple-ascending cohort 2 |
| Cohort 8 | Experimental | Drug: Cohort 8 (JP-1366 H mg)Multiple-ascending cohort 3 |
| Cohort 9 | Experimental | Drug: Cohort 9 (JP-1366 I mg)Multiple-ascending cohort 4 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males aged between 19 and 50 at screening
- Weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Key exclusion criteria (5 listed)
- Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- Subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- Subject has been Helicobacter pylori positive
- AST (SGOT) and ALT (SGPT) > 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
- Subject has anatomical disability in insertion and maintenance of pH meter catheter
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 |
|---|---|---|
| Cohort 1 (JP-1366 A mg)Also: SADDrug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 1 |
| Cohort 2 (JP-1366 B mg)Also: SADDrug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 2 |
| Cohort 3 (JP-1366 C mg)Also: SADDrug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 3 |
| Cohort 4 (JP-1366 D mg)Also: SADDrug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 4 |
| Cohort 5 (JP-1366 E mg)Also: SADDrug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 5 |
| Cohort 6 (JP-1366 F mg)Also: MADDrug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 6 |
| Cohort 7 (JP-1366 G mg)Also: MADDrug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 7 |
| Cohort 8 (JP-1366 H mg)Also: MADDrug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 8 |
| Cohort 9 (JP-1366 I mg)Also: MADDrug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg | Drug | Cohort 9 |
Primary outcome
Cmax
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
AUClast
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
AUCinf
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
tmax
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
t1/2
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
SAD endpoint
Cmax,ss
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Cmin,ss
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Cav,ss
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
AUCτ
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
tmax,ss
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
t1/2
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
MAD endpoint
Percentage of total time that the intragastric pH was above 4
Time frame: 0-24 hours(Day -1), 0-24 hours(Day 1)
SAD
Percentage of total time that the intragastric pH was above 4
Time frame: 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7)
MAD
Serum gastrin concentration
Time frame: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose
SAD
Serum gastrin concentration
Time frame: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24h post-dose, Day 4 pre-dose, Day 6 pre-dose, Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose
MAD
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 22 Apr 2019.
- Individual participant dataSharing planned: No
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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 Cohort 1 (JP-1366 A mg), Cohort 2 (JP-1366 B mg) and Cohort 3 (JP-1366 C mg) in people with Anti-Ulcer Agents, run by Jeil 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 5 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 22 Apr 2019. 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?
Cmax (time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose). The study lists 15 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 22 Apr 2019.