Status:
WITHDRAWN
Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers
Lead Sponsor:
Sequella, Inc.
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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 d...
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/Exc...
Eligibility Criteria
Inclusion
- Major
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01252108
Start Date
March 1 2012
End Date
August 1 2015
Last Update
November 17 2015
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