Study of CT001 in Healthy Volunteers

Cessatech

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: sufentanil; Drug: CT001; Drug: Ketamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04807335

PDC 01-0204

Details and patient eligibility

About

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

Full description

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

Enrollment: 14 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Investigational medicinal product CT001

Experimental group

Description:

intranasal dosage of CT001

Treatment:

Drug: CT001

Comparator 1

Active Comparator group

Description:

Ketamine 10mg iv

Treatment:

Drug: Ketamine

Comparator 2

Active Comparator group

Description:

Sufentanil 10mcg iv

Treatment:

Drug: sufentanil