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

NCT05924321 | Completed Phase 1 FDA Drug

• 1 other identifier: 000421
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (3)

• Observed Heart rate(HR) values

  Part A

  Up to 240 minutes after Start of Infusion

• Change from baseline of HR (∆HR).

  Part A

  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).

  Part B

  Up to 24 hours after Start of Infusion

Secondary Outcomes (84)

• Treatment-emergent adverse events (TEAEs)

  Up to follow-up visit (7 to 10 days after the last dose)

• Vital signs; Systolic blood pressure and Diastolic blood pressure

  Up to follow-up visit (7 to 10 days after the last dose)

• Vital signs; Pulse rate

  Up to follow-up visit (7 to 10 days after the last dose)

• Vital signs; Body temperature

  Up to follow-up visit (7 to 10 days after the last dose)

• Vital signs; Respiratory rate

  Up to follow-up visit (7 to 10 days after the last dose)

Study Arms (3)

Carbetocin

EXPERIMENTAL

Single IV infusion of carbetocin

Drug: Carbetocin

Placebo

PLACEBO COMPARATOR

Single IV Infusion of matching placebo

Drug: Placebo

Placebo and Moxifloxacin

ACTIVE COMPARATOR

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

Drug: Placebo and Moxifloxacin

Interventions

Carbetocin DRUG

Single infusion of Carbetocin

Carbetocin

Placebo DRUG

Single IV infusion of matching placebo

Placebo

Placebo and Moxifloxacin DRUG

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

Placebo and Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Ferring Investigational Site

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; Moxifloxacin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 29, 2023
• Study Start: May 25, 2023
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: September 3, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)