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To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291418
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Antibe Therapeutics Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Gastric Ulcer Drug: ATB-346 OR Placebo Drug: Naproxen sodium Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Encapsulated tablets
Primary Purpose: Prevention
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
Actual Study Start Date : September 8, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Comparison of gastrointestinal effects

Active Comparator: Naproxen sodium
Intervention: Drug: naproxen sodium dosed orally at 550 mg twice daily for 14 days
Drug: Naproxen sodium
Comparison of gastrointestinal effects
Other Name: Naprosyn




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Gastroduodenal ulcers >=5mm diameter [ Time Frame: At completion of 14 days of oral dosing ]
    Incidence of gastric or duodenal ulcers of at least 5 mm diameter with unequivocal depth

  2. gastroduodenal erosions [ Time Frame: At completion of 14 days of oral dosing ]
    Number of gastric and/or duodenal erosions and/or ulcers

  3. Dyspepsia [ Time Frame: At completion of 14 days of oral dosing ]
    Incidence of dyspepsia leading to study withdrawal

  4. Hematocrit [ Time Frame: At completion of 14 days of oral dosing ]
    Change from baseline in hematocrit levels

  5. Thromboxane B2 levels [ Time Frame: At completion of 14 days of oral dosing ]
    Changes from baseline in ex vivo whole blood thromboxane B2 (TXB2) synthesis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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-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.

Exclusion Criteria:

  • 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:

    1. NSAIDs, Aspirin, aspirin-containing products or naproxen-containing medications, NSAID-containing products
    2. Proton pump inhibitors
    3. H-2 blockers
    4. Anti-platelet 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.

      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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291418


Locations
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Canada, Ontario
Topstone Clinical Research
Toronto, Ontario, Canada, M9C 4Z5
Sponsors and Collaborators
Antibe Therapeutics Inc.
Investigators
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Principal Investigator: Deepen Patel, MD Topstone Clinical Research

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Responsible Party: Antibe Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03291418    
Other Study ID Numbers: ATB-346-P2GIS
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Antibe Therapeutics Inc.:
Healthy Volunteers, ATB-346, Naproxen sodium, GI safety
Additional relevant MeSH terms:
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Stomach Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action