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

Study Overview
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Brief Summary
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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.

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

Conditions
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Analgesia

Intervention / Treatment
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* Combination Product: CT001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study population will receive a target dose of intranasal CT001 corresponding to sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg (and an additional dose 10 -15 minutes after, if needed) prior to an elective surgical, procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>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<br>* Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.<br>|

What is the study measuring?
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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 |