Bioavailability
Conditions
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.
Interventions
Sponsors
Dantrials Aps
Smerud Medical Research International AS
Cessatech A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, |
| 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 |
Countries
Denmark
Outcome results
None listed