Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy, adult, male or female subjects, 18-45 years of age, inclusive, at the screening visit.
Body mass index (BMI) ≥ 18.5 and ≤29.9 kg/m2 at the screening visit.
Continuous non-smoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to first dosing.
You may not be if
Sustained supine systolic blood pressure ≥130 mmHg or \<90 mmHg, supine diastolic blood pressure ≥80 mmHg or \<50 mmHg at screening or first check-in.
History or presence of clinically significant ECG findings in the opinion of the Principal Investigator (PI) or designee at the screening visit or first check-in, including each of the following:
* HR \<45 bpm or \>100 bpm.
* QTcF is ≥450 msec (males) or ≥460 msec (females).
* QRS ≥110 msec; if ≥110 msec, result will be confirmed by a manual over read.
* PR ≥200 msec.
History or presence of:
* Risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT syndrome, Brugada syndrome, or sudden cardiac death).
* Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, angina, pulmonary congestion, symptomatic or significant cardiac arrhythmia, or clinically significant conduction abnormalities.
* Clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia, in the opinion of the PI or designee.
Clareo Health | A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
