Status:
COMPLETED
Study of CT001 in Healthy Volunteers
Lead Sponsor:
Cessatech A/S
Collaborating Sponsors:
Dantrials Aps
Smerud Medical Research International AS
Conditions:
Bioavailability
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04807335
Start Date
March 17 2021
End Date
June 2 2021
Last Update
August 24 2021
Active Locations (1)
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1
Dantrials
Copenhagen, DK, Denmark, 2400