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

NCT04897750 | Completed Phase 2

• 1 other identifier: PDC 01-0206
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Analgetic effect

  0 - 1 hour

• Sedation

  0 - 1 hour

• Feasibility, (Acceptance of intranasal administration)

  0- 4 hours

Study Arms (1)

Active

EXPERIMENTAL

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

Interventions

CT001 COMBINATION_PRODUCT

Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.

Active

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cessatech A/S: lead

Study Sites (1)

Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret

Copenhagen, Region H, 2100, Denmark

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Volker Classen, MD

  Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 21, 2021
• Study Start: August 19, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)