Tuberculosis
Conditions
Keywords
tuberculosis, SQ109, QTc, moxifloxacin, crossover, placebo, pharmacokinetic, randomized, single-center
Brief summary
This will be a single center, open label, crossover study to evaluate the safety and tolerability of multiple dose levels of SQ109.
Detailed description
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.
Interventions
DRUGSQ109
300mg or 450mg of SQ109 administered orally, once daily for 7 days.
OTHERSQ109 Placebo
Placebo is a round, coated, yellow, unscored tablet. SQ109 Placebo administered orally, once daily for 7 days.
DRUGMoxifloxacin
400mg of moxifloxacin (positive control) administered orally, once daily for 7 days.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women aged 18 to 45 years, inclusive. * Ability to understand the consent process and procedures. * Informed consent obtained and signed. * Comprehension of the study objectives and procedures which will be determined by the recruiter using a series of questions after explaining the procedures. * Subject agrees to be available for all study visits and is able to comply with protocol requirements for the entire duration of the study. * Subject agrees not to participate in another clinical trial at any time during the study period. * Subjects who have a body mass index (BMI) \>/=18 kg/m\^2 and \</= 35 kg/m\^2 * General good health, without current medical illness or clinically significant abnormal physical examination findings that classify the subject as other than healthy as determined by study investigators * Negative serum pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for all female subjects of child bearing potential. * Negative urine toxicity screen for alcohol, marijuana, cocaine metabolite, amphetamines, opiates, PCP, barbiturates, and benzodiazepines. * Agreement by subjects with reproductive potential to use an adequate method of contraception during the study and for 90 days after study drug administration. Female subjects must agree to the use of two reliable methods of contraception while receiving study drug and for 90 days after study drug administration, which can include: condoms, spermicidal gel, diaphragm, hormonal or non-hormonal intrauterine device, surgical sterilization, oral contraceptive pill, and depot progesterone injections. If a male subject is heterosexually active, the subject and his partner must use at least two forms of the listed contraceptive methods.
Exclusion criteria
Subjects meeting any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 300mg/day SQ109 | 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 | Days 1-7 of each dosing period and 30 days after last dosing period. |
Secondary
| Measure | Time frame |
|---|---|
| Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 450mg/day SQ109 | 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 | 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 | Days 1-7 of each dosing period and 30 days after last dosing period. |
Countries
United States
Outcome results
None listed