Analgesic Efficacy and Pharmacokinetic-pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 after Impacted Mandibular Third Molar Extractio

Phase 1

• Conditions: Healthy male or female participants scheduled for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.; MedDRA version: 21.0Level: LLTClassification code 10050327Term: Dental surgery NOSSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2021-003258-21-DK
• Lead Sponsor: Cessatech A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-04
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Healthy (The American Society of Anaesthesiologists’ Physical Classification System (ASA) I-II) male or female participants scheduled
for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.
2. Ability to understand spoken and written Danish
3. Written informed consent for participation in the study
4. Age: > 18 and < 55 years
5. Body Mass index above (>)18.5 or below (<) 30.0 kg/m2
6. Physical examination, including blood pressure, pulse rate, ECG and laboratory assessment without clinically significant abnormalities. A
potential participant with measurements outside of the reference range for the population being studied may be included at the investigator´s
discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures.
7. A woman of childbearing potential is eligible to participate if she is not pregnant, nor breastfeeding, and agrees to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment
8. Prior to randomisation: Numeric Pain Rating Scale (NRS anchored by 0 = no pain”, 10 = worst pain imaginable”) = 5 at rest within 4 hours after the administration of the last dose of local anaesthetic
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential subject at risk when
participating in the study, or influence the potential subject’s ability to participate in the study or influence the study results.
2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely
to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure
3. History of increased bleeding tendency
4. Clinically significant mental illness
5. Opioid Risk Tool score of >3
6. Pain Catastrophizing Scale score, total points >30
7. Hospital Anxiety and Depression Scale (HADS), points =11 for anxiety or
=11 points for depression
8. Daily intake of analgesics
9. Daily use of tobacco, including snuff
10. History of alcohol or drug abuse or use of illicit drugs or positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of the investigational medicinal product.
11. Use of prescription drugs within 14 days (including low-dose acetylsalicylic acid [<150 mg/day]) or over-the-counter drugs 24 hours
except paracetamol, which is allowed until 6 pm the day before surgery (intranasal medication 48 hours, ibuprofen max 400 mg/day) prior to the
first dose of study medication, unless it is the opinion of the Investigator that the medication will not interfere with the study procedures or
compromise the participant.
12. Any scheduled invasive treatment or medical/surgical procedure during the study period, except surgical removal of an impacted mandibular third
molar
13. Abnormal nasal cavity/airway such as: a. evidence of previous significant nasal disorder including
surgery, or dependence of inhaled drug b. current significant nasal congestion due to common cold
c. minimum air flow during the nasal passages (evaluated at the investigator’s discretion)
14. History or presence of hypersensitivity or allergy to sufentanil, ketamine, NSAIDs or local anaesthetics, a history of anaphylactic or anaphylactoid
reactions, or a history of other allergy that, in the opinion of the investigator, contraindicates the participation.
15. Positive COVID-19 test or clinical symptoms of COVID-19 (testing of potential participants will follow the health authorities’ guidelines and
current local guidelines)
16. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial
17. Previous randomisation to treatment in the present study
18. Blood or plasma donation within 4 weeks prior to the dosing procedure visit (Visit 3 [Day 0]).
19. Chronic pain as judged by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified