Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures

Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.

This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9 paediatric participants >6-17 years.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Combination product: CT001

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Copenhagen, Region H, Denmark, 2100
      • Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Paediatric participants, age 1-17 years at the day of the surgical procedure
• Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
• ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
• Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
• Needs premedication before induction of anaesthesia as determined by investigator
• Informed consent by the legally acceptable representative(s)
• The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
• A female participant who has onset of menarche is eligible to participate if she is not pregnant, not breastfeeding and agree to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment.

Exclusion Criteria:

• Ex-premature infant (born <37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
• Mental retardation
• Abnormal nasal cavity or nasal obstruction
• Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
• Medical history including substance or alcohol abuse
• Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
• Has planned perioperative administration of sufentanil and/or ketamine
• Has or is suspected of having a family or personal history of malignant hyperthermia
• Has or is suspected of having allergies to ketamine or sufentanil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; a target dose of intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, (2-4 puffs) and an additional dose if needed as premedication before placement of a PVC for induction of anaesthesia.	Combination product: CT001; Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total absorption over time	Area under the concentration vs time curve	0 - 120 minutes
Maximum absorption	Peak concentration (Cmax)	0 - 120 minutes
Distribution	Volumen of distribution (Vd)	120 - 240 minutes
Elimination	Half life (T½)	120 - 240 minutes
Elimination	Clearance,	120 - 240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgetic effect	pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter	0 - 1 hour
Sedation	Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score	0 - 1 hour
Feasibility, (Acceptance of intranasal administration)	Acceptance of the intranasal route of administration by the child, assessed by the child or legally acceptable representative or health care provider.	0- 4 hours

Collaborators and Investigators

• Sponsor: Cessatech A/S
• Investigators: Principal Investigator: Volker Classen, MD, Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PDC 01-0206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No