Study of CT001 in Healthy Volunteers

Bioavailability Clinical Trial

Official title:

Bioavailability Study of Intranasal CT001 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807335
• Other study ID #: PDC 01-0204
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2021
• Est. completion date: June 2, 2021

Study information

• Verified date: August 2021
• Source: Cessatech A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• CT001
nasal spray
• Ketamine
iv single dose
• sufentanil
iv single dose

Locations

Country	Name	City	State
Denmark	Dantrials	Copenhagen	DK

Sponsors (3)

Lead Sponsor	Collaborator
Cessatech A/S	Dantrials Aps, Smerud Medical Research International AS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	number of study participants with adverse events	Number andproportion of adverse events,	from baseline to 48 hours post dose
Secondary	elimination of CT001	Half time	from baseline to 48 hours
Secondary	vital signs	heart rate, blood pressure, respiratory rate and blood oxygen level	from baseline to 48 hours

External Links

•   sponsor's homepage