This will be a single center, open label, crossover study to evaluate the safety and tolerability of multiple dose levels of SQ109.
This is a Phase 1, randomized, single-center, clinical study of SQ109 to evaluate the potential for this drug to produce QTc prolongation. The study population is healthy male and female subjects, aged 18-45 years. Pharmacokinetics of SQ109 will be measured using interval plasma samples.The overall study design will incorporate within it a four-period investigation suitable for the QT evaluation of an active study treatment. The primary goal of the sample size considerations will be to ensure that the sample size employed during this phase of the study will be adequate to ensure a high likelihood of a successful demonstration of the QT safety of 300 and 450 mg/day SQ109. All subjects will be randomized to a sequence of three seven-day dosing periods, with each dosing period occurring once per subject. The final seven-day dosing period will occur after the first sequence of three dosing periods is completed. A washout period of at least seven days will occur between all dosing periods, and a follow-up visit will occur.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
300mg or 450mg of SQ109 administered orally, once daily for 7 days.
Placebo is a round, coated, yellow, unscored tablet. SQ109 Placebo administered orally, once daily for 7 days.
400mg of moxifloxacin (positive control) administered orally, once daily for 7 days.
Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine
Cleveland, Ohio, United States
Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 300mg/day SQ109
Time frame: Days 1-7 of each dosing period and 30 days after last dosing period.
Electrocardiogram and holter monitor data (QTc, T wave forms, QRS, RR and PR intervals) for 300mg/day SQ109
Time frame: Days 1-7 of each dosing period and 30 days after last dosing period.
Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 450mg/day SQ109
Time frame: Days 1-7 of each dosing period and 30 days after last dosing period.
Pharmacokinetics of SQ109 at doses of 300 or 450mg/day; AUC0-, (Cmax), time to maximum concentration (Tmax), elimination rate constant, elimination half-life, clearance, volume of distribution, and urinary excretion
Time frame: Day 1 and Day 6 of each dosing period
Electrocardiogram and holter monitor data (QTc, T wave forms, QRS, RR and PR intervals) for 450mg/day SQ109
Time frame: Days 1-7 of each dosing period and 30 days after last dosing period.
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