Study of CT001 in Healthy Volunteers

Bioavailability Study of Intranasal CT001 in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Drug: CT001; Drug: Ketamine; Drug: sufentanil

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Copenhagen, DK, Denmark, 2400
      • DanTrials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cessatech A/S
• Collaborators: Smerud Medical Research International AS; Dantrials Aps
• Investigators: Principal Investigator: Mads Werner, MD, Rigshospitalet, Denmark

Publications and helpful links

Helpful Links

• sponsor's homepage

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ketamine; Sufentanil
• Other Study ID Numbers: PDC 01-0204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No