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

What Was Tested

This registered phase 1 trial tested Carbetocin.

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.

It had three arms (groups): Carbetocin (experimental), Placebo (placebo comparator) and Placebo and Moxifloxacin (active comparator).

Single IV infusion of carbetocin.

Single IV Infusion of matching placebo.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: 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; HR \<45 bpm or \>100 bpm; QTcF is ≥450 msec (males) or ≥460 msec (females).

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this Carbetocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Carbetocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Carbetocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-05-25 with completion listed for 2023-09-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Observed Heart rate(HR) values (time frame: Up to 240 minutes after Start of Infusion). Change from baseline of HR (∆HR) (time frame: Up to 240 minutes after Start of Infusion). Placebo-corrected change from baseline in QT interval (∆∆QTc) using the most appropriate HR correction method (i.e., ∆∆QTcF if Fridericia's method is used) (time frame: Up to 24 hours after Start of Infusion).

It also tracked 84 secondary outcomes, for example Treatment-emergent adverse events (TEAEs), Vital signs; Systolic blood pressure and Diastolic blood pressure, Vital signs; Pulse rate, Vital signs; Body temperature, Vital signs; Respiratory rate and 12-lead safety ECGs.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Carbetocin in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carbetocin compound page, all human trials.