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.
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.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
During the 14 days of drug adminstration and 14 days of follow-up
Frank Lanza, MD
Houston Institute for Clinical Research
United States: Food and Drug Administration