Healthy VolunteersPhase 1NCT03407872
Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers
A Phase 1 study testing Esketamine DPI in people with Healthy Volunteers, run by Celon Pharma SA at 1 site in Poland.
Trial summary
The planned study is to determine the pharmacokinetic properties of Esketamine and safety assessment with inhaled Esketamine after different number of inhalations and different dosing sequences within three parts of the study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Esketamine DPI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 sitePoland
- Study dates
- 9 Dec 2017to 19 Jun 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian female or male,
- Age: 18-55 years old, inclusive,
- Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2
- Non-smoker and nonuser of tobacco products for at least 1 year before screening,
- Physical examination without any clinically relevant abnormality,
- Laboratory values not clinically significant,
- Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.
Who cannot join
- Known allergy or hypersensitivity to ketamine or its derivates and/or to any study product excipients,
- Any known significant current or past acute or chronic disease or condition,
- Participation in other clinical trial within 90 days preceding the screening,
- Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
- Positive results from pregnancy test for female participants,
- Lactation in women participants,
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- Hypotension or hypertension in medical history,
- Narcotic, alcohol addiction or abuse,
- Participant who adhere to a special diet (e.g. low calories, vegetarian).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-centre Safety and Pharmacokinetics Phase I Study of Inhaled Esketamine in Healthy Volunteers With Two Single Ascending Dose and One Double-blind Multiple Ascending Dose Parts
The planned study is to determine the pharmacokinetic properties of Esketamine and safety assessment with inhaled Esketamine after different number of inhalations and different dosing sequences within three parts of the study.
Read the detailed description
This is to be one-centre, single ascending dose and double-blind placebo controlled multiple dose three part study of Esketamine DPI (dry powder inhaler) in healthy volunteers.
PART A is a single dose, open-label part with Esketamine DPI inhalations administered with dose escalation between cohorts.
PART B is a single dose, open-label part with Esketamine DPI inhalations administered in different dosing sequences with dose escalation between cohorts.
PART C is a multiple dose, double-blind, placebo-controlled part with Esketamine DPI inhalations administered in different cycles of treatment (with four dosing sequences within two weeks) with dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio.
Pharmacokinetic properties and safety of Esketamine DPI will be determined following different number of inhalations in PART A, different dosing sequences in PART B and different cycles of treatment in PART C.
- Conditions
- Healthy Volunteers
- Being tested
- Esketamine DPI, Placebo DPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine DPIDrug
Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.
Esketamine DPIDrug
Participants will receive different dosing sequences of Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A of the study.
Dose: very low, low, medium, high.
Esketamine DPIDrug
Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. There will be dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A and PART B of the study.
Dose: very low, low, medium, high.
Placebo DPIDrug
Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio.
In each cohort, number of placebo inhalations within a dosing sequence will correspond to number of Esketamine DPI inhalations.
| Study group | Role | What they receive |
|---|---|---|
| PART A | Experimental | 6 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts. Receives: Drug: Esketamine DPI |
| PART B | Experimental | 4 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts. Receives: Drug: Esketamine DPI |
| PART C | Experimental | 4 cohorts will receive multiple dose of Esketamine DPI in two weeks' time administered with dose escalation between cohorts. Receives: Drug: Esketamine DPI |
| PART C placebo | Placebo comparator | 4 cohorts will receive multiple dose of matching placebo in two weeks' time. Receives: Drug: Placebo DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - maximum Esketamine plasma concentration
The maximum concentration of the Esketamine in plasma after drug administration, obtained directly from the measured concentrations.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
AUC (0-24) - area under the Esketamine plasma concentration-time curve from time 0 to 24 hours after study drug administration
The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after study drug administration.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
Number of inhalations needed to achieve the assumed Esketamine antidepressive plasma concentration.
Measured: up to 24 hours after study drug administration in PART A
Number of inhalations within dosing sequence needed to maintain the assumed Esketamine antidepressive plasma concentration.
Measured: up to 24 hours after study drug administration in PART B
Secondary outcomes (8)
AUC (0-inf) - area under the Esketamine plasma concentration-time curve from time 0 to infinity time
The AUC(0-inf) is a measure of total plasma exposure to the drug from time point zero extrapolated to infinity.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
Tmax - time to reach maximum Esketamine plasma concentration
The Tmax is time to reach the maximum plasma concentration (Cmax), obtained directly from the actual sampling times.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
Kel -elimination rate constant
Kel will be estimated via linear regression of time versus log of concentration.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
T1/2 - plasma elimination half-life for Esketamine
T1/2 will be calculated as 0.693/Kel.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
Cmax - maximum Esnorketamine plasma concentration
The maximum concentration of the Esnorketamine in plasma after drug administration, obtained directly from the measured concentrations. Esnorketamine is Esketamine's main metabolite.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
AUC (0-24) - area under the Esnorketamine plasma concentration-time curve from time 0 to 24 hours after study drug administration.
The AUC(0-24) is a measure of total Esnorketamine plasma exposure to the metabolite from time point zero to 24 hours after study drug administration. Esnorketamine is Esketamine's main metabolite.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
Tmax - time to reach maximum Esnorketamine plasma concentration.
The Tmax is time to reach the maximum Esnorketamine plasma concentration (Cmax), obtained directly from the actual sampling times. Esnorketamine is Esketamine's main metabolite.
Measured: up to 24 hours after each study drug administration in PART A, B and C of the study.
Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs).
Participants during hospitalization will be closely observed to assure maximal safety and to collect occurrence of all adverse event. To follow-up on all study participants telephone calls with a request for information regarding their health condition will be made. All adverse events will be collected with special attention to occurrence of psychotomimetic and dissociative effects after study drug administration.
Measured: up to 7 days in PART A and PART B of the study and up to 25 days in PART C of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start9 Dec 2017
- Primary completion20 May 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celon Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407872
- Sponsor's protocol ID
- 01KET2017
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2018
- Last updated
- 12 Jul 2018
- 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 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-centre Safety and Pharmacokinetics Phase I Study of Inhaled Esketamine in Healthy Volunteers With Two Single Ascending Dose and One Double-blind Multiple Ascending Dose Parts
- ClinicalTrials.gov ID
- NCT03407872
- Acronym / sponsor ID
- 01KET2017
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Celon Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 9 Dec 2017 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 23 Jan 2018 (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.
The planned study is to determine the pharmacokinetic properties of Esketamine and safety assessment with inhaled Esketamine after different number of inhalations and different dosing sequences within three parts of the study.
Detailed description
This is to be one-centre, single ascending dose and double-blind placebo controlled multiple dose three part study of Esketamine DPI (dry powder inhaler) in healthy volunteers.
PART A is a single dose, open-label part with Esketamine DPI inhalations administered with dose escalation between cohorts.
PART B is a single dose, open-label part with Esketamine DPI inhalations administered in different dosing sequences with dose escalation between cohorts.
PART C is a multiple dose, double-blind, placebo-controlled part with Esketamine DPI inhalations administered in different cycles of treatment (with four dosing sequences within two weeks) with dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio.
Pharmacokinetic properties and safety of Esketamine DPI will be determined following different number of inhalations in PART A, different dosing sequences in PART B and different cycles of treatment in PART C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PART A | Experimental | Drug: Esketamine DPI6 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts. |
| PART B | Experimental | Drug: Esketamine DPI4 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts. |
| PART C | Experimental | Drug: Esketamine DPI4 cohorts will receive multiple dose of Esketamine DPI in two weeks' time administered with dose escalation between cohorts. |
| PART C placebo | Placebo comparator | Drug: Placebo DPI4 cohorts will receive multiple dose of matching placebo in two weeks' time. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Caucasian female or male,
- Age: 18-55 years old, inclusive,
- Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2
- Non-smoker and nonuser of tobacco products for at least 1 year before screening,
- Physical examination without any clinically relevant abnormality,
Key exclusion criteria (9 listed)
- Known allergy or hypersensitivity to ketamine or its derivates and/or to any study product excipients,
- Any known significant current or past acute or chronic disease or condition,
- Participation in other clinical trial within 90 days preceding the screening,
- Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
- Positive results from pregnancy test for female participants,
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 |
|---|---|---|
| Esketamine DPIParticipants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. | Drug | PART A |
| Esketamine DPIParticipants will receive different dosing sequences of Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A of the study. Dose: very low, low, medium, high. | Drug | PART B |
| Esketamine DPIParticipants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. There will be dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A and PART B of the study. Dose: very low, low, medium, high. | Drug | PART C |
| Placebo DPIParticipants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. In each cohort, number of placebo inhalations within a dosing sequence will correspond to number of Esketamine DPI inhalations. | Drug | PART C placebo |
Primary outcome
Cmax - maximum Esketamine plasma concentration
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
The maximum concentration of the Esketamine in plasma after drug administration, obtained directly from the measured concentrations.
AUC (0-24) - area under the Esketamine plasma concentration-time curve from time 0 to 24 hours after study drug administration
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after study drug administration.
Number of inhalations needed to achieve the assumed Esketamine antidepressive plasma concentration.
Time frame: up to 24 hours after study drug administration in PART A
Number of inhalations within dosing sequence needed to maintain the assumed Esketamine antidepressive plasma concentration.
Time frame: up to 24 hours after study drug administration in PART B
8 secondary outcomes
AUC (0-inf) - area under the Esketamine plasma concentration-time curve from time 0 to infinity time
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
Tmax - time to reach maximum Esketamine plasma concentration
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
Kel -elimination rate constant
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
T1/2 - plasma elimination half-life for Esketamine
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
Cmax - maximum Esnorketamine plasma concentration
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
AUC (0-24) - area under the Esnorketamine plasma concentration-time curve from time 0 to 24 hours after study drug administration.
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
Tmax - time to reach maximum Esnorketamine plasma concentration.
Time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.
Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs).
Time frame: up to 7 days in PART A and PART B of the study and up to 25 days in PART C of the study.
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 12 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Esketamine DPI in people with Healthy Volunteers, run by Celon Pharma SA at 1 site in Poland.
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 7 inclusion and 9 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 12 Jul 2018. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Cmax - maximum Esketamine plasma concentration (time frame: up to 24 hours after each study drug administration in PART A, B and C of the study.). The study lists 4 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 12 Jul 2018.