Helicobacter Pylori InfectionPhase 2NCT01252108
Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers
A Phase 2 study testing SQ109 in people with Helicobacter Pylori Infection, run by Sequella, Inc..
Trial summary
Helicobacter pylori infection of the gastric epithelium is the most common bacterial infection worldwide. Its global prevalence is estimated at 50%, though the burden falls disproportionately on the developing world, where the prevalence in some areas is 80%. H. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- SQ109
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Aug 2015
- Phase
- Phase 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Major Inclusion Criteria:
- Subject must be 18 to 45 years of age (inclusive).
- Subject must have 2 positive Urea Breath Tests (UBT) obtaining during screening, and no other clinically significant disease (i.e., hematology, clinical chemistries and urinalysis tests must be within study-defined ranges (See Appendix B). Clinical tests must be performed within 14 days of receiving first dose of study drug.
- Body Mass Index (BMI) must be between 18 and 30 kg/m2 inclusive.
- Subject must be able to give voluntary written informed consent before any study related procedure is performed.
- If female, has no childbearing potential or agrees to avoid becoming pregnant from the day of screening through their entire participation in the trial (Day 42) by using one of the following acceptable methods of birth control plus recommended use of a barrier method (condom) by the male partner (even if vasectomized):
- intrauterine contraceptive device; or
- diaphragm in combination with contraceptive jelly, cream, or foam; or
- spermicide; or
- abstinence.
Major Exclusion Criteria:
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which would jeopardize the safety of the subject or impact the validity of the study results.
- Abnormal diet during the 4 weeks preceding the study.
- Use of any OTC or prescription medication, including vitamins and herbal supplements, within 7 days prior to Day 1 of the study, unless the substance would not likely impact on the conduct of this study.
- Current medical condition (other than H. pylori infection) requiring treatment with medication, either prescription or OTC.
- Treatment with any known CYP450 enzyme altering drugs such as azoles, antifungals, barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to Day 1 of the study.
- Positive blood screen for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody and/or a positive urine screen for alcohol or drugs of abuse.
- Baseline QTc interval >450 msec (males) or >470 msec (females)or a family history of prolonged QTc syndrome or premature cardiac death.
About this study
Official title: Phase 2A Open-label Study to Evaluate Safety, Tolerability, and Antimicrobial Activity of Single, Daily Doses of SQ109 in Urea Breath Test Positive Volunteers
Helicobacter pylori infection of the gastric epithelium is the most common bacterial infection worldwide. Its global prevalence is estimated at 50%, though the burden falls disproportionately on the developing world, where the prevalence in some areas is 80%. H. pylori infection is generally acquired during childhood, and without specific antibiotic treatment can persist for life. The infection is generally clinically asymptomatic during childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic (although they may transmit the bacteria).
SQ109 is a new, small molecule antibiotic with characteristics that make it particularly attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable, acid-stable, has in vitro activity against H. pylori and achieves high intracellular concentration (which may be important to effect bacterial eradication).
Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori. Data from this study will help determine whether larger safety and efficacy studies in individuals with H. pylori-associated duodenal ulcer disease are warranted.
Read the detailed description
A total of 30 Urea Breath Test (UBT)-Positive volunteers will be enrolled. Each subject will receive SQ109 150 mg bid with PPI or 300 mg qd by mouth daily for 14 consecutive days.
Major Inclusion/Exclusion Criteria:
- Subject must be 18 to 45 years of age (inclusive).
- Subject must have 2 positive Urea Breath Tests (UBT) obtaining during screening, and no other clinically significant disease (i.e., hematology, clinical chemistry and urinalysis tests must be within study-defined ranges. Clinical tests must be performed within 14 days of receiving first dose of study drug.
- Body Mass Index (BMI) must be between 18 and 33 kg/m2 inclusive.
- Subject must be able to give voluntary written informed consent before any study related procedure is performed.
Objectives:
- To determine the safety and tolerability of SQ109 administered daily for 14 consecutive days in male and female Urea Breath Test (UBT)-positive subjects.
- To assess antimicrobial activity against H. pylori of SQ109 administered daily for 14 days in UBT-positive subjects.
Design: Each subject will undergo screening evaluations within 14 days of study entry (Day 1) and baseline evaluations Day -14 and Day -2 to Day 1 (up to 14 days prior to the first dose). On Day 1 (first day of dosing), the subject will be administered study drug and undergo the Day 1 procedures. Throughout the 14 days of treatment phase of the study each subject will be assessed daily for adverse events (AEs). Laboratory safety evaluations will be performed on Day 7, 8, 9, or 10, and on Day 14, and Day 21. On Days 1, 4, 7, 10, 14, 21, and 28 each subject will have a UBT. On Follow-up Days 21 and 28 each subject will return to the study unit to have safety assessments.
Outcome Measures:
Safety and tolerability will be evaluated by a review of physical examinations, neurological examinations, vital signs assessments, 12-lead ECGs, routine clinical laboratory tests (including chemistry and hematology data), and AE assessments.
Efficacy Outcome Measures consist of serial UBT assessments for evidence of H. pylori in the gastrointestinal tract collected at baseline, during the 14 days of SQ109 administration, and during the 14 day follow-up period.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- SQ109
- Keywords
- Helicobacter pylori, peptic ulcer disease, stomach ulcers, gastric cancer
- Medical subject headings
- Peptic Ulcer, Stomach Ulcer, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ109Drug
300 mg SQ109 daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects receive SQ109 Receives: Drug: SQ109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of SQ109 against H. pylori measured by Urea Breath Test Results
In addition to assessment of safety and tolerability of SQ109, Preliminary efficacy will be assessed by serial Urea Breath Tests during the 14 days of drug administration, and recurrence will be assessed during the 14 days following the last dose of study drug.
Measured: During the 14 days of drug adminstration and 14 days of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequella, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lanza, MD, Principal investigator, Houston Institue for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252108
- Sponsor's protocol ID
- SQ109-H001
- Status last verified
- Nov 2015
- First submitted
- 30 Nov 2010
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2A Open-label Study to Evaluate Safety, Tolerability, and Antimicrobial Activity of Single, Daily Doses of SQ109 in Urea Breath Test Positive Volunteers
- ClinicalTrials.gov ID
- NCT01252108
- Acronym / sponsor ID
- SQ109-H001
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, peptic ulcer disease, stomach ulcers, gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sequella, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Dec 2010 (estimated)
- 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.
Helicobacter pylori infection of the gastric epithelium is the most common bacterial infection worldwide. Its global prevalence is estimated at 50%, though the burden falls disproportionately on the developing world, where the prevalence in some areas is 80%. H. pylori infection is generally acquired during childhood, and without specific antibiotic treatment can persist for life. The infection is generally clinically asymptomatic during childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic (although they may transmit the bacteria).
SQ109 is a new, small molecule antibiotic with characteristics that make it particularly attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable, acid-stable, has in vitro activity against H. pylori and achieves high intracellular concentration (which may be important to effect bacterial eradication).
Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori. Data from this study will help determine whether larger safety and efficacy studies in individuals with H. pylori-associated duodenal ulcer disease are warranted.
Detailed description
A total of 30 Urea Breath Test (UBT)-Positive volunteers will be enrolled. Each subject will receive SQ109 150 mg bid with PPI or 300 mg qd by mouth daily for 14 consecutive days.
Major Inclusion/Exclusion Criteria:
- Subject must be 18 to 45 years of age (inclusive).
- Subject must have 2 positive Urea Breath Tests (UBT) obtaining during screening, and no other clinically significant disease (i.e., hematology, clinical chemistry and urinalysis tests must be within study-defined ranges. Clinical tests must be performed within 14 days of receiving first dose of study drug.
- Body Mass Index (BMI) must be between 18 and 33 kg/m2 inclusive.
- Subject must be able to give voluntary written informed consent before any study related procedure is performed.
Objectives:
- To determine the safety and tolerability of SQ109 administered daily for 14 consecutive days in male and female Urea Breath Test (UBT)-positive subjects.
- To assess antimicrobial activity against H. pylori of SQ109 administered daily for 14 days in UBT-positive subjects.
Design: Each subject will undergo screening evaluations within 14 days of study entry (Day 1) and baseline evaluations Day -14 and Day -2 to Day 1 (up to 14 days prior to the first dose). On Day 1 (first day of dosing), the subject will be administered study drug and undergo the Day 1 procedures. Throughout the 14 days of treatment phase of the study each subject will be assessed daily for adverse events (AEs). Laboratory safety evaluations will be performed on Day 7, 8, 9, or 10, and on Day 14, and Day 21. On Days 1, 4, 7, 10, 14, 21, and 28 each subject will have a UBT. On Follow-up Days 21 and 28 each subject will return to the study unit to have safety assessments.
Outcome Measures:
Safety and tolerability will be evaluated by a review of physical examinations, neurological examinations, vital signs assessments, 12-lead ECGs, routine clinical laboratory tests (including chemistry and hematology data), and AE assessments.
Efficacy Outcome Measures consist of serial UBT assessments for evidence of H. pylori in the gastrointestinal tract collected at baseline, during the 14 days of SQ109 administration, and during the 14 day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: SQ109All subjects receive SQ109 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| SQ109300 mg SQ109 daily for 14 days | Drug | Treatment |
Primary outcome
Activity of SQ109 against H. pylori measured by Urea Breath Test Results
Time frame: During the 14 days of drug adminstration and 14 days of follow-up
In addition to assessment of safety and tolerability of SQ109, Preliminary efficacy will be assessed by serial Urea Breath Tests during the 14 days of drug administration, and recurrence will be assessed during the 14 days following the last dose of study drug.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Frank Lanza, MD principal investigator
Houston Institue for Clinical Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SQ109 in people with Helicobacter Pylori Infection, run by Sequella, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Activity of SQ109 against H. pylori measured by Urea Breath Test Results (time frame: During the 14 days of drug adminstration and 14 days of follow-up). 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 17 Nov 2015.