A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects

Ferring

Status and phase: Completed; Phase 1

Conditions: Postpartum Hemorrhage

Treatments: Drug: Placebo; Drug: Placebo and Moxifloxacin; Drug: Carbetocin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05924321

000421

Details and patient eligibility

About

Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature. Carbetocin is approved in >100 countries for the prevention of postpartum hemorrhage due to uterine atony in women following cesarean or vaginal delivery. Per regulatory requirements, the current trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval corrected for heart rate (QTc) as measured by ECG in healthy men and women.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups, including a placebo group

Carbetocin

Experimental group

Description:

Single IV infusion of carbetocin

Treatment:

Drug: Carbetocin

Placebo

Placebo Comparator group

Description:

Single IV Infusion of matching placebo

Treatment:

Drug: Placebo

Placebo and Moxifloxacin

Active Comparator group

Description:

Single IV infusion of matching placebo with a single oral dose of moxifloxacin

Treatment:

Drug: Placebo and Moxifloxacin