A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-43… (NCT01941446) | Clinical Trial Compass
CompletedPhase 1
A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization
54 participantsStarted 2013-03
Plain-language summary
This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through 3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4 nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a minimum of a 14 day washout between treatments.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male and female subjects of 18 to 55 years of age;
. Females must be surgically sterile (hysterectomy and/or bilateral oophorectomy), post-menopausal for 1 year (with follicle-stimulating hormone \[FSH\] in menopausal range), or agree to use 2 medically accepted, effective methods of birth control (e.g., hormonal contraception, including oral, implant/patch, or injection, or latex condom with spermicide, diaphragm with intravaginal spermicide, cervical cap with spermicide, or indwelling intrauterine device) from the time of signing informed consent until 2 weeks after the Follow-Up Visit. One of the birth control methods must be a barrier method;
. Male subjects with sexual partners of childbearing potential must agree to use 2 medically accepted, effective methods of birth control (e.g., hormonal contraception, including oral, implant/patch, or injection, or latex condom with spermicide, diaphragm with intravaginal spermicide, cervical cap with spermicide, or indwelling intrauterine device) for the duration of the study and for 90 days after the Follow-up Visit. Male subjects who have had a vasectomy \>6 months prior to the first dose of study drug must agree to use 1 medically accepted barrier method for the duration of the study and for 90 days after the Follow-up Visit;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the effect of a therapeutic dose of an IV infusion of eravacycline (TP-434) on cardiac repolarization compared to placebo
. Male subjects (including those who have had vasectomies \>6 months prior to the first dose of study drug) whose partners are currently pregnant must agree to use a barrier method (without spermicide) for the duration of the study and for 2 weeks after the Follow-up Visit;
. Body mass index of 18 kg/m2 to 33 kg/m2, inclusive;
. Non-smokers must have quit smoking \>3 months prior to the Screening Visit;
. Have negative alcohol and drug screens;
. Have a quantitative urine cotinine screen \<3;
Exclusion criteria
. Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, or allergic disease (including multiple or clinically significant drug allergies), cancer, or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, interfere with the integrity of electrophysiologic data, or place the subject at an unacceptable risk as a participant in this study;
. A personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias or family history of sudden death;
. Mean QTcF interval \>450 msec on screening ECG, performed in triplicate. The mean QTcF of these tracings will be used by the Investigator;
. Cardiac conduction abnormalities denoted by any of the following at the Screening Visit: evidence of second-degree (Mobitz type II) or third-degree atrioventricular block, evidence of ventricular pre-excitation, complete left bundle branch block, right bundle branch block, intraventricular conduction delay with QRS duration \>120 msec, atrial fibrillation, or presence of cardiac pacemaker; PR interval \>220 msec or \<120 msec; heart rate \<45 bpm or \>90 bpm; other clinically-significant ECG abnormalities (measured as a mean value from triplicate ECGs);
. Use of hormone replacement therapy;
. Any major surgical procedure within 3 months prior to the first dose of study drug;
. Gastrointestinal disorders or surgical procedures that could interfere significantly with the absorption of orally administered drugs;
. Use of another investigational drug or device within 30 days prior to receiving eravacycline (TP-434), or within at least 5 half-lives of the previous investigational drug, whichever is longer;