ClinicalTrials.gg
CompletedNCT03291418Updated Jun 6, 2018

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 interventional study of ATB-346 OR Placebo and Naproxen sodium in Gastric Ulcer, sponsored by Antibe Therapeutics Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Antibe Therapeutics Inc. (part of Sun Pharmaceutical Industries Limited) · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gastric Ulcer

Browse trials for

Keywords

  • Healthy Volunteers, ATB-346, Naproxen sodium, GI safety
03

In context

Stomach Ulcer

116 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 258 is below the median of 298 across 88 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Antibe Therapeutics Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    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-, as per investigator discretion 4. ≤35 kg/m2 5. Non-smoker for >1 month prior to screening 6. Subject able and willing to give written , and understand and adhere to protocol requirements 7. Female of using adequate 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.

        1. 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.
        1. Screening endoscopy is free from any observable gastroduodenal erosions or ulcers, and no greater than 10 mucosal petechiae.

Exclusion criteria

Exclusion Criteria:

    1. Subject with abnormal baseline laboratory values deemed to be 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 and hormone replacement therapy) 3. Use of drugs up to thirty (30) days before screening 4. Use of the following medications within two weeks prior to randomization:

      1. NSAIDs, Aspirin, aspirin-containing products or naproxen-containing medications, NSAID-containing products
      2. Proton pump inhibitors
      3. H-2 blockers
      4. Anti- agents
      5. Anti-coagulants
      6. Antimicrobials
      7. 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.

        1. 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.
        1. 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 to naproxen, other non-steroidal anti-inflammatory (NSAID) agents, related products (including 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 antigen/antibody combination, surface antigen (HBsAg), or anti- 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
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
258 participants (actual)

Study arms

  • Experimental
    ATB-346 OR Placebo

    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

    Drug: ATB-346 OR Placebo

  • Active comparator
    Naproxen sodium

    Intervention: Drug: naproxen sodium dosed orally at 550 mg twice daily for 14 days

    Drug: Naproxen sodium

Interventions

  • DrugATB-346 OR Placebo

    Comparison of gastrointestinal effects

  • Comparison of gastrointestinal effects

    Also known as: Naprosyn

06

What researchers measure

Primary outcomes

  1. Gastroduodenal ulcers >=3mm diameter

    Incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth

    Time frame: At completion of 14 days of oral dosing

Secondary outcomes

  1. Gastroduodenal ulcers >=5mm diameter

    Incidence of gastric or duodenal ulcers of at least 5 mm diameter with unequivocal depth

    Time frame: At completion of 14 days of oral dosing

  2. gastroduodenal erosions

    Number of gastric and/or duodenal erosions and/or ulcers

    Time frame: At completion of 14 days of oral dosing

  3. Dyspepsia

    Incidence of dyspepsia leading to study withdrawal

    Time frame: At completion of 14 days of oral dosing

  4. Hematocrit

    Change from baseline in hematocrit levels

    Time frame: At completion of 14 days of oral dosing

  5. Thromboxane B2 levels

    Changes from baseline in ex vivo whole blood thromboxane B2 (TXB2) synthesis

    Time frame: At completion of 14 days of oral dosing

07

Study locations

1 site
  • Topstone Clinical Research
    Toronto, Ontario M9C 4Z5, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Mar 2018, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 25, 2017
StartActual
Sep 8, 2017
Primary completionActual
Mar 31, 2018
CompletionActual
Apr 30, 2018
Last update
Jun 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03291418
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Sep 8, 2017
Primary completion
Mar 31, 2018
Completion
Apr 30, 2018
Last update
Jun 6, 2018

Study contacts

Deepen Patel, MD
principal investigator · Topstone Clinical Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion