Study of CT001 in Healthy Volunteers

Study Overview
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Brief Summary
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A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.

Detailed Description
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A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.

Official Title
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Bioavailability Study of Intranasal CT001 in Healthy Volunteers

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: CT001
* Drug: Ketamine
* Drug: sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational medicinal product CT001<br>intranasal dosage of CT001 | Drug: CT001<br>* nasal spray<br>|
| Active Comparator: Comparator 1<br>Ketamine 10mg iv | Drug: Ketamine<br>* iv single dose<br>|
| Active Comparator: Comparator 2<br>Sufentanil 10mcg iv | Drug: sufentanil<br>* iv single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of CT001 in the blood | maximum concentration over time C(max), | baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose | 
| Total amount of CT001 in the blood over time | Area under the curve calculated from t=0 to t= 48 hours | baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distribution and elimination of CT001 | Volume of distribution | baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose | 
| number of study participants with adverse events | Number andproportion of adverse events, | from baseline to 48 hours post dose | 
| elimination of CT001 | Half time | from baseline to 48 hours | 
| vital signs | heart rate, blood pressure, respiratory rate and blood oxygen level | from baseline to 48 hours |