BioavailabilityPhase 1NCT04807335
Study of CT001 in Healthy Volunteers
A Phase 1 study testing CT001, Ketamine and sufentanil in people with Bioavailability, run by Cessatech A/S at 1 site in Denmark.
Trial summary
A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- CT001, Ketamine and sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2021to 2 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability Study of Intranasal CT001 in Healthy Volunteers
A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.
Read the detailed description
A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.
- Conditions
- Bioavailability
- Being tested
- CT001, Ketamine, sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT001Drug
nasal spray
KetamineDrug
iv single dose
sufentanilDrug
iv single dose
| Study group | Role | What they receive |
|---|---|---|
| Investigational medicinal product CT001 | Experimental | intranasal dosage of CT001 Receives: Drug: CT001 |
| Comparator 1 | Active comparator | Ketamine 10mg iv Receives: Drug: Ketamine |
| Comparator 2 | Active comparator | Sufentanil 10mcg iv Receives: Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of CT001 in the blood
maximum concentration over time C(max),
Measured: 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
Measured: 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
Volume of distribution
Measured: 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
Number andproportion of adverse events,
Measured: from baseline to 48 hours post dose
elimination of CT001
Half time
Measured: from baseline to 48 hours
vital signs
heart rate, blood pressure, respiratory rate and blood oxygen level
Measured: from baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start17 Mar 2021
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cessatech A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dantrials Aps, Smerud Medical Research International AS
- Responsible party
- Sponsor
- Investigators
- Mads Werner, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807335
- Sponsor's protocol ID
- PDC 01-0204
- Status last verified
- Aug 2021
- First submitted
- 17 Mar 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of Intranasal CT001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04807335
- Acronym / sponsor ID
- PDC 01-0204
- Conditions
- Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cessatech A/SIndustry (pharma, biotech, devices)
- Collaborators
- Dantrials Aps, Smerud Medical Research International AS
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.
Detailed description
A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational medicinal product CT001 | Experimental | Drug: CT001intranasal dosage of CT001 |
| Comparator 1 | Active comparator | Drug: KetamineKetamine 10mg iv |
| Comparator 2 | Active comparator | Drug: sufentanilSufentanil 10mcg iv |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT001nasal spray | Drug | Investigational medicinal product CT001 |
| Ketamineiv single dose | Drug | Comparator 1 |
| sufentaniliv single dose | Drug | Comparator 2 |
Primary outcome
concentration of CT001 in the blood
Time frame: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
maximum concentration over time C(max),
Total amount of CT001 in the blood over time
Time frame: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
Area under the curve calculated from t=0 to t= 48 hours
4 secondary outcomes
distribution and elimination of CT001
Time frame: 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
Time frame: from baseline to 48 hours post dose
elimination of CT001
Time frame: from baseline to 48 hours
vital signs
Time frame: from baseline to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- sponsor's homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Bioavailability
RecruitingPhase 1
Effects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults
NAD+ Metabolism, Pharmacokinetics
Not yet recruiting
Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis
End Stage Kidney Disease (ESKD), Hemodialysis
Not yet recruiting
A Clinical Trial to Assess the Absorption, Safety, and Efficacy of an Oral Nicotinamide Adenine Dinucleotide (NAD+) Supplement in Healthy Adults
NAD+ Bioavailability, NAD+ Safety
Not yet recruiting
To Assess Dose Proportionality and Pharmacokinetic Linearity of Saninova Tablets in Healthy Participants Under Fasting Conditions
Bioavailability and Pharmacokinetics
Active, not recruiting
Bioavailability of Phlorotannins and Carotenoids Following the Intake of Crackers Fortified With Seaweed
Bioavailability Heathy Volunteers, Bioavailability and AUC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mads Werner, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT001, Ketamine and sufentanil in people with Bioavailability, run by Cessatech A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of CT001 in the blood (time frame: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.