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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2023-09-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The trial will consist of two parts; Part A and Part B. Part A is an open-label single group trial while Part B is a double-blind trial with 3 groups.

Study Groups

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Carbetocin

Single IV infusion of carbetocin

Group Type EXPERIMENTAL

Carbetocin

Intervention Type DRUG

Single infusion of Carbetocin

Placebo

Single IV Infusion of matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single IV infusion of matching placebo

Placebo and Moxifloxacin

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

Group Type ACTIVE_COMPARATOR

Placebo and Moxifloxacin

Intervention Type DRUG

Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin

Interventions

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Carbetocin

Single infusion of Carbetocin

Intervention Type DRUG

Placebo

Single IV infusion of matching placebo

Intervention Type DRUG

Placebo and Moxifloxacin

Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes