Phase 2A Open-label Study to Evaluate Safety, Tolerability, and Antimicrobial Activity of Single, Daily Doses of SQ109 in Urea Breath Test Positive Volunteers
18 Years
45 Years
Both
Helicobacter Pylori Infection
Trial Information
Phase 2A Open-label Study to Evaluate Safety, Tolerability, and Antimicrobial Activity of Single, Daily Doses of SQ109 in Urea Breath Test Positive Volunteers
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:
1. Subject must be 18 to 45 years of age (inclusive).
2. 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.
3. Body Mass Index (BMI) must be between 18 and 33 kg/m2 inclusive.
4. Subject must be able to give voluntary written informed consent before any study
related procedure is performed.
Objectives:
1. To determine the safety and tolerability of SQ109 administered daily for 14 consecutive
days in male and female Urea Breath Test (UBT)-positive subjects.
2. 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.
Major
Inclusion Criteria:
1. Subject must be 18 to 45 years of age (inclusive).
2. 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.
3. Body Mass Index (BMI) must be between 18 and 30 kg/m2 inclusive.
4. Subject must be able to give voluntary written informed consent before any study
related procedure is performed.
5. 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):
1. intrauterine contraceptive device; or
2. diaphragm in combination with contraceptive jelly, cream, or foam; or
3. spermicide; or
4. abstinence.
Major Exclusion Criteria:
1. 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.
2. Abnormal diet during the 4 weeks preceding the study.
3. 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.
4. Current medical condition (other than H. pylori infection) requiring treatment with
medication, either prescription or OTC.
5. 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.
6. 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.
7. Baseline QTc interval >450 msec (males) or >470 msec (females)or a family history of
prolonged QTc syndrome or premature cardiac death.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Activity of SQ109 against H. pylori measured by Urea Breath Test Results
Outcome Description:
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.
Outcome Time Frame:
During the 14 days of drug adminstration and 14 days of follow-up
Safety Issue:
No
Principal Investigator
Frank Lanza, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Houston Institute for Clinical Research
Authority:
United States: Food and Drug Administration
Study ID:
SQ109-H001
NCT ID:
NCT01252108
Start Date:
March 2012
Completion Date:
August 2013
Related Keywords:
- Helicobacter Pylori Infection
- Helicobacter pylori
- peptic ulcer disease
- stomach ulcers
- gastric cancer
- Helicobacter Infections
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