Study of CT001 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-06-02

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.

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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.

Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Investigational medicinal product CT001

intranasal dosage of CT001

Group Type EXPERIMENTAL

CT001

Intervention Type DRUG

nasal spray

Comparator 1

Ketamine 10mg iv

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

iv single dose

Comparator 2

Sufentanil 10mcg iv

Group Type ACTIVE_COMPARATOR

sufentanil

Intervention Type DRUG

iv single dose

Interventions

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CT001

nasal spray

Intervention Type DRUG

Ketamine

iv single dose

Intervention Type DRUG

sufentanil

iv single dose

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes