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

Bioavailability

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source