Study of CT001 in Healthy Volunteers
- Registration Number
- NCT04807335
- Lead Sponsor
- Cessatech A/S
- Brief Summary
A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.
- Detailed Description
A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
- Age from 18 up to 55 years
- Non-smokers
- Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as American Society of Anesthesiologists (ASA)
- Physical Status Class 1 or 2
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values.
Exclusion Criteria
- Mental illness
- Opioid Risk Tool score of >3
- Pain Catastrophizing Scale score, total points >30
- Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression
- Daily intake of analgesics
- History of alcohol or drug abuse or use of illicit drugs.
- 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.
- Participant showing abnormal nasal cavity/airway
- History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy.
- Positive tests for HIV, hepatitis B and hepatitis C
- Positive COVID-19 test or clinical symptoms of COVID-19
- 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
- Blood donation within 4 weeks prior to the first dosing visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Investigational medicinal product CT001 CT001 intranasal dosage of CT001 Comparator 2 sufentanil Sufentanil 10mcg iv Comparator 1 Ketamine Ketamine 10mg iv
- Primary Outcome Measures
Name Time Method concentration of CT001 in the blood baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose maximum concentration over time C(max),
Total amount of CT001 in the blood over time baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose Area under the curve calculated from t=0 to t= 48 hours
- Secondary Outcome Measures
Name Time Method elimination of CT001 from baseline to 48 hours Half time
vital signs from baseline to 48 hours heart rate, blood pressure, respiratory rate and blood oxygen level
distribution and elimination of CT001 baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose Volume of distribution
number of study participants with adverse events from baseline to 48 hours post dose Number andproportion of adverse events,
Trial Locations
- Locations (1)
Dantrials
🇩🇰Copenhagen, DK, Denmark