Clinical trial investigating bioavailability of sufentanil and ketamine in combination as nasal spray in healthy male volunteers

Phase 1

• Conditions: ot applicable - healthy volunteers; MedDRA version: 22.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004488-14-DK
• Lead Sponsor: Cessatech A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-14
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

i) Healthy volunteers; male
ii) Age from 18 up to 55 years
iii) Non-smokers
iv) Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2
v) Categorized as ASA Physical Status Class 1 or 2
vi) Clinically normal medical history, physical findings, vital signs, ECG and laboratory values as judged by the investigator at the time of the screening visit. 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.
vii) The potential participant gives written informed consent for participation in the study
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

i)Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential participant at risk when participating in the study, or influence the potential participant’s ability to participate in the study or influence the study results.
ii.) 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
iii.) Mental illness
iv.) Opioid Risk Tool score of >3
v.) Pain Catastrophizing Scale score, total points >30
vi.) Hospital Anxiety and Depression Scale (HADS), points =11 for anxiety or =11 points for depression
vii.) Daily intake of analgesics
viii.) History of alcohol or drug abuse or use of illicit drugs Positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of investigational product.
ix.) Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) 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 participant
x.) Participants who have planned any scheduled invasive treatment or medical/surgical procedure during the study period
xi.) Participant showing abnormal nasal cavity/airway such as:
a. major septal deviation
b. evidence of previous nasal disease, surgery, and dependence of inhaled drug
c. current significant nasal congestion due to common cold
d. minimum air flow during each nasal passage
xii.) History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation
xiii.) Positive tests for HIV, hepatitis B and hepatitis C
xiv.) Positive COVID-19 test or clinical symptoms of COVID-19 (testing of participants will follow the health authorities’ guidelines and current guidelines for the Capital Region of Denmark)
xv.) 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
xvi.) Blood donation within 4 weeks prior to the first dosing visit

Study & Design

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