Study of CT001 in Healthy Volunteers

• Sponsor: Cessatech A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04807335
• Collaborator: Dantrials Aps (Industry), Smerud Medical Research International AS (Other)
• Enrollment: 14
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bioavailability	Drug: CT001; Drug: Ketamine; Drug: sufentanil	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Bioavailability Study of Intranasal CT001 in Healthy Volunteers
• Actual Study Start Date: Mar 17, 2021
• Actual Primary Completion Date: Jun 2, 2021
• Actual Study Completion Date: Jun 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational medicinal product CT001 intranasal dosage of CT001	Drug: CT001; nasal spray
Active Comparator: Comparator 1 Ketamine 10mg iv	Drug: Ketamine; iv single dose
Active Comparator: Comparator 2 Sufentanil 10mcg iv	Drug: sufentanil; iv single dose

Outcome Measures

Primary Outcome Measures

1. 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),

2. 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

1. 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

2. number of study participants with adverse events [from baseline to 48 hours post dose]

   Number andproportion of adverse events,

3. elimination of CT001 [from baseline to 48 hours]

   Half time

4. vital signs [from baseline to 48 hours]

   heart rate, blood pressure, respiratory rate and blood oxygen level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dantrials	Copenhagen	DK	Denmark	2400

Sponsors and Collaborators

• Cessatech A/S
• Dantrials Aps
• Smerud Medical Research International AS

Investigators

• Principal Investigator: Mads Werner, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• sponsor's homepage

Publications

None provided.

• Responsible Party: Cessatech A/S
• ClinicalTrials.gov Identifier: NCT04807335
• Other Study ID Numbers: PDC 01-0204
• First Posted: Mar 19, 2021
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sufentanil; Ketamine

Study Results

No Results Posted as of Aug 24, 2021