NCT04807335

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

March 17, 2021

Last Update Submit

August 23, 2021

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • distribution and elimination of CT001

    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

    from baseline to 48 hours post dose

  • elimination of CT001

    from baseline to 48 hours

  • vital signs

    from baseline to 48 hours

Study Arms (3)

Investigational medicinal product CT001

EXPERIMENTAL

intranasal dosage of CT001

Drug: CT001

Comparator 1

ACTIVE COMPARATOR

Ketamine 10mg iv

Drug: Ketamine

Comparator 2

ACTIVE COMPARATOR

Sufentanil 10mcg iv

Drug: sufentanil

Interventions

CT001DRUG

nasal spray

Investigational medicinal product CT001
KetamineDRUG

iv single dose

Comparator 1
sufentanilDRUG

iv single dose

Comparator 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dantrials

Copenhagen, DK, 2400, Denmark

Location

Related Links

MeSH Terms

Interventions

KetamineSufentanil

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mads Werner, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 19, 2021

Study Start

March 17, 2021

Primary Completion

June 2, 2021

Study Completion

June 2, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)