Gastric UlcerPhase 1/2NCT03291418
To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
A Phase 1/2 study testing Naproxen sodium in people with Gastric Ulcer, run by Antibe Therapeutics Inc. at 1 site in Canada.
Trial summary
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- Naproxen sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2017to 30 Apr 2018
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult subjects ≥18 to ≤65 years of age 2. Healthy subject with no history of significant gastrointestinal (GI) disease, arthritis or bleeding disorders 3. Subject with laboratory values within normal and acceptable ranges or out of range laboratory values deemed non-clinically significant, as per investigator discretion 4. BMI ≤35 kg/m2 5. Non-smoker for >1 month prior to screening 6. Subject able and willing to give written informed consent, and understand and adhere to protocol requirements 7. Female of childbearing potential using adequate birth control for at least 28 days prior to the first dose of the study drug and for 60 days after the last drug administration, as specified in one of the options below:
- Abstinence from heterosexual intercourse
- Contraception to include birth control pills, injectable/implant/transdermal patch
- Intrauterine device
- Cervical cap or diaphragm with use of spermicide
- Condom with spermicide Male subjects with female partners of childbearing potential must agree to abstain from sexual intercourse or use on the above forms of contraception for a period of 3 months following the last drug administration.
- 8. Female of non-childbearing potential who is either sterile (via complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state for at least one year 9. Subject who consumes no more than 1 alcoholic serving/drink per day (e.g. 355 mL (12 fluid (fl) ounces (oz)) of regular beer; 148 mL (5 fl oz) of wine; 45 mL (1.5 fl oz) of distilled spirits) 10. Subject willing to refrain from alcohol consumption for 48 hours prior to the screening endoscopy and randomization, and 48 hours prior to the Day 14 endoscopy.
- 11. Screening endoscopy is free from any observable gastroduodenal erosions or ulcers, and no greater than 10 mucosal petechiae.
Who cannot join
- 1. Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator 2. Ongoing use of any prescription or over-the-counter medications, or natural/herbal or vitamin preparations, that in the opinion of the Investigator would interfere with the study objectives, or impact subject safety (with the exception of systemic contraceptives and hormone replacement therapy) 3. Use of investigational drugs up to thirty (30) days before screening 4. Use of the following medications within two weeks prior to randomization:
- NSAIDs, Aspirin, aspirin-containing products or naproxen-containing medications, NSAID-containing products
- Proton pump inhibitors
- H-2 blockers
- Anti-platelet agents
- Anti-coagulants
Show all 10Show fewer
- Antimicrobials
- Other gastroprotective agents such as antacids, misoprostol, or bismuth-containing products 5. Subject-reported past history of gastrointestinal ulcer or gastrointestinal bleeding, or any clinically significant gastrointestinal disease.
- 6. Positive for Helicobacter pylori urea breath test at the screening visit 7. Clinically significant gastrointestinal, hepatic or renal disease, or any other conditions known to significantly impact or interfere with absorption, distribution, metabolism or elimination of the investigational drug(s) 8. Clinically significant past or present diseases or illnesses that, in the opinion of the investigator, would interfere with the study objectives or integrity or with the subject's safety.
- 9. Subject with seated pulse rates <50 beats per minute (bpm) or >100 bpm at screening 10. Seated blood pressure <100/60 mm Hg or >140/90 mm Hg at screening 11. Known hypersensitivities to naproxen, other non-steroidal anti-inflammatory (NSAID) agents, related products (including excipients and formulations) 12. Known hypersensitivities to drugs used for sedation during endoscopy 13. Severe hypersensitivity (including angioedema) to any drugs 14. Use of medications with known drug-drug interactions including potent enzyme-modifying drugs, potent inhibitors and/or inducers of CYP enzymes (such as fluoxetine, barbiturates or St. John's Wort) in the previous thirty (30) days before randomization 15. Female who is pregnant or breastfeeding 16. Positive test for HIV antigen/antibody combination, hepatitis B surface antigen (HBsAg), or anti-Hepatitis C virus tests 17. Positive urine drug test at screening 18. Positive urine alcohol test prior to the screening endoscopy 19. Any clinically significant illness up to thirty (30) days before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
Read the detailed description
Healthy male and female subjects (n=240) are randomized into two dose groups of 120 subjects each. Gastroduodenal endoscopies are performed pre-dose and post-dose, i.e., after 14 days of either ATB-346 (250 mg once daily) or naproxen sodium (550 mg twice daily) and the incidence of gastric mucosal damage is recorded for comparison between the two treatment arms.
- Conditions
- Gastric Ulcer
- Being tested
- ATB-346 OR Placebo, Naproxen sodium
- Keywords
- Healthy Volunteers, ATB-346, Naproxen sodium, GI safety
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB-346 OR PlaceboDrug
Comparison of gastrointestinal effects
Naproxen sodiumDrug
Also called Naprosyn
Comparison of gastrointestinal effects
| Study group | Role | What they receive |
|---|---|---|
| ATB-346 OR Placebo | Experimental | Intervention: Drug: ATB-346 dosed orally at 250 mg once daily for 14 days Intervention: Drug: Placebo (for ATB-346) dosed once daily for 14 days Receives: Drug: ATB-346 OR Placebo |
| Naproxen sodium | Active comparator | Intervention: Drug: naproxen sodium dosed orally at 550 mg twice daily for 14 days Receives: Drug: Naproxen sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroduodenal ulcers >=3mm diameter
Incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth
Measured: At completion of 14 days of oral dosing
Secondary outcomes (5)
Gastroduodenal ulcers >=5mm diameter
Incidence of gastric or duodenal ulcers of at least 5 mm diameter with unequivocal depth
Measured: At completion of 14 days of oral dosing
gastroduodenal erosions
Number of gastric and/or duodenal erosions and/or ulcers
Measured: At completion of 14 days of oral dosing
Dyspepsia
Incidence of dyspepsia leading to study withdrawal
Measured: At completion of 14 days of oral dosing
Hematocrit
Change from baseline in hematocrit levels
Measured: At completion of 14 days of oral dosing
Thromboxane B2 levels
Changes from baseline in ex vivo whole blood thromboxane B2 (TXB2) synthesis
Measured: At completion of 14 days of oral dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start8 Sep 2017
- Primary completion31 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antibe Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepen Patel, MD, Principal investigator, Topstone Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291418
- Sponsor's protocol ID
- ATB-346-P2GIS
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03291418
- Acronym / sponsor ID
- ATB-346-P2GIS
- Conditions
- Gastric Ulcer
- Keywords
- Healthy Volunteers, ATB-346, Naproxen sodium, GI safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Antibe Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 25 Sep 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.
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
Detailed description
Healthy male and female subjects (n=240) are randomized into two dose groups of 120 subjects each. Gastroduodenal endoscopies are performed pre-dose and post-dose, i.e., after 14 days of either ATB-346 (250 mg once daily) or naproxen sodium (550 mg twice daily) and the incidence of gastric mucosal damage is recorded for comparison between the two treatment arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATB-346 OR Placebo | Experimental | Drug: ATB-346 OR PlaceboIntervention: Drug: ATB-346 dosed orally at 250 mg once daily for 14 days Intervention: Drug: Placebo (for ATB-346) dosed once daily for 14 days |
| Naproxen sodium | Active comparator | Drug: Naproxen sodiumIntervention: Drug: naproxen sodium dosed orally at 550 mg twice daily for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Adult subjects ≥18 to ≤65 years of age 2. Healthy subject with no history of significant gastrointestinal (GI) disease, arthritis or bleeding disorders 3. Subject with laboratory values within normal and acceptable ranges or out of range laboratory values deemed non-clinically significant, as per investigator discretion 4. BMI ≤35 kg/m2 5. Non-smoker for >1 month prior to screening 6. Subject able and willing to give written informed consent, and understand and adhere to protocol requirements 7. Female of childbearing potential using adequate birth control for at least 28 days prior to the first dose of the study drug and for 60 days after the last drug administration, as specified in one of the options below:
- 8. Female of non-childbearing potential who is either sterile (via complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state for at least one year 9. Subject who consumes no more than 1 alcoholic serving/drink per day (e.g. 355 mL (12 fluid (fl) ounces (oz)) of regular beer; 148 mL (5 fl oz) of wine; 45 mL (1.5 fl oz) of distilled spirits) 10. Subject willing to refrain from alcohol consumption for 48 hours prior to the screening endoscopy and randomization, and 48 hours prior to the Day 14 endoscopy.
- 11. Screening endoscopy is free from any observable gastroduodenal erosions or ulcers, and no greater than 10 mucosal petechiae.
Key exclusion criteria (10 listed)
- 1. Subject with abnormal baseline laboratory values deemed to be clinically significant by the Investigator 2. Ongoing use of any prescription or over-the-counter medications, or natural/herbal or vitamin preparations, that in the opinion of the Investigator would interfere with the study objectives, or impact subject safety (with the exception of systemic contraceptives and hormone replacement therapy) 3. Use of investigational drugs up to thirty (30) days before screening 4. Use of the following medications within two weeks prior to randomization:
- 6. Positive for Helicobacter pylori urea breath test at the screening visit 7. Clinically significant gastrointestinal, hepatic or renal disease, or any other conditions known to significantly impact or interfere with absorption, distribution, metabolism or elimination of the investigational drug(s) 8. Clinically significant past or present diseases or illnesses that, in the opinion of the investigator, would interfere with the study objectives or integrity or with the subject's safety.
- 9. Subject with seated pulse rates <50 beats per minute (bpm) or >100 bpm at screening 10. Seated blood pressure <100/60 mm Hg or >140/90 mm Hg at screening 11. Known hypersensitivities to naproxen, other non-steroidal anti-inflammatory (NSAID) agents, related products (including excipients and formulations) 12. Known hypersensitivities to drugs used for sedation during endoscopy 13. Severe hypersensitivity (including angioedema) to any drugs 14. Use of medications with known drug-drug interactions including potent enzyme-modifying drugs, potent inhibitors and/or inducers of CYP enzymes (such as fluoxetine, barbiturates or St. John's Wort) in the previous thirty (30) days before randomization 15. Female who is pregnant or breastfeeding 16. Positive test for HIV antigen/antibody combination, hepatitis B surface antigen (HBsAg), or anti-Hepatitis C virus tests 17. Positive urine drug test at screening 18. Positive urine alcohol test prior to the screening endoscopy 19. Any clinically significant illness up to thirty (30) days before screening
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 |
|---|---|---|
| ATB-346 OR PlaceboComparison of gastrointestinal effects | Drug | ATB-346 OR Placebo |
| Naproxen sodiumAlso: NaprosynComparison of gastrointestinal effects | Drug | Naproxen sodium |
Primary outcome
Gastroduodenal ulcers >=3mm diameter
Time frame: At completion of 14 days of oral dosing
Incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth
5 secondary outcomes
Gastroduodenal ulcers >=5mm diameter
Time frame: At completion of 14 days of oral dosing
gastroduodenal erosions
Time frame: At completion of 14 days of oral dosing
Dyspepsia
Time frame: At completion of 14 days of oral dosing
Hematocrit
Time frame: At completion of 14 days of oral dosing
Thromboxane B2 levels
Time frame: At completion of 14 days of oral dosing
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 6 Jun 2018.
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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.
Deepen Patel, MD principal investigator
Topstone Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Naproxen sodium in people with Gastric Ulcer, run by Antibe Therapeutics Inc. at 1 site in Canada.
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 8 inclusion and 10 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 6 Jun 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 Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Gastroduodenal ulcers >=3mm diameter (time frame: At completion of 14 days of oral dosing). 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 6 Jun 2018.