CompletedPhase 1ketamine
Study of CT001 in Healthy Volunteers
Sponsored by Cessatech A/S
NCT ID
NCT04807335
Target Enrollment
14 participants
Start Date
2021-03-17
Est. Completion
2021-06-02
About This Study
A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.
Conditions Studied
Interventions
- •CT001
- •Ketamine
- •sufentanil
Eligibility
Sex:MALE
Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
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 Locations (1)
Dantrials
Copenhagen, DK, Denmark