HealthyPhase 1NCT02060929
A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device
A Phase 1 study testing Esketamine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine using a device with and without a nasal guide in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Jan 2014
- 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
- Agrees to protocol-defined use of effective contraception
- If a woman, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
- Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Who cannot join
- Current or prior history of psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
- Clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders , lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic disease, infection, hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea, myasthenia gravis, or any other illness
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study center (Day -1 of each treatment period) as deemed appropriate by the investigator
- Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, noisy breathing during sleep, facial pain, headaches, and postnasal drip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase 1 Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device
The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine using a device with and without a nasal guide in healthy participants.
Read the detailed description
This is a randomized (the study medication is assigned by chance), single-center, single-dose, 2-way crossover (participants may receive different interventions sequentially during the study in 2 sequence groups), open-label (all people know the identity of the intervention) study. Approximately, 14 participants will be enrolled in this study. This study will consist of a screening phase of up to 21 days, a treatment phase of 3 days, and a follow-up phase of 9-13 days. Participants will be randomly allocated to 1 of the 2 treatment groups (Sequence 1 and 2). In sequence 1, participants will self-administer esketamine intranasally using a device with nasal guide as treatment A on Day 1 of period 1 and intranasally esketamine using a device without nasal guide as treatment B on Day 1 of period 2. In sequence 2, participants will self-administer intranasally esketamine as treatment B on Day 1 of period 1 and intranasally esketamine as treatment A on Day 1 of period 2. There will be a washout period of 5 to 10 days between each treatment regimen. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, pulse oximetry, targeted nasal examination, nasal device questionnaire, and in addition to these evaluations, specific scales will be used to assess the safety. The study duration for each participant will be approximately 45 days.
- Conditions
- Healthy
- Being tested
- Esketamine
- Keywords
- Healthy, Esketamine, Intranasal, Nasal Guide, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Participants will self administer 1 spray of esketamine solution using a intranasal device with a nasal guide in Treatment A regimen and without nasal guide inTreatment B regimen at time 0 and repeated twice every 5 minutes (total dose: 84 mg).
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will self administer 1 spray of esketamine solution to each nostril using a intranasal (through nose) device with a nasal guide on Day 1 of period 1 as treatment regimen A at time 0 and repeated twice every 5 minutes (total dose: 84 mg). There will be a washout period of 5-10 days between the treatment regimens. On Day 1 of period 2, participants will self administer 1 spray of esketamine solution to each nostril using a intranasal device without a nasal guide as treatment regimen B at time 0 and repeated twice every 5 minutes (total dose: 84 mg). Receives: Drug: Esketamine |
| Sequence 2 | Experimental | Participants will self administer 1 spray of esketamine solution to each nostril using a intranasal device without a nasal guide on Day 1 of period 1 as treatment regimen B at time 0 and repeated twice every 5 minutes (total dose: 84 mg). There will be a washout period of 5-10 days between the treatment regimens. On Day 1 of period 2, participants will self administer 1 spray of esketamine solution to each nostril using a intranasal device with a nasal guide as treatment regimen A at time 0 and repeated twice every 5 minutes (total dose: 84 mg). Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Esketamine
Cmax is defined as maximum observed analyte concentration.
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Esketamine
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of Esketamine
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Esketamine
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Elimination Half-Life Period (T1/2) of Esketamine
T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
First-order Rate Constant of Esketamine
First-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Relative Bioavailability (Frel) of Esketamine
Relative bioavailability is the percentage of the administered dose that is systemically available.
Measured: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Change From Baseline in Clinician-Administered Dissociative States Scale (CADSS) Score
The CADSS is a clinician administered rating scale designed to measure dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: depersonalization, derealization and amnesia. Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely). Higher scores indicate worsening.
Measured: Baseline (Day -1) and Day 2
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Score
The BPRS is used for the measurement of psychiatric symptoms. The BPRS is an 18 item questionnaire and each question is rated on a 7-point scale ranging from 1 (not present) to 7 (extremely severe). The total score for the 18 question will be calculated by adding score of each question. The interpretation of the total scores are: 0-9 will indicate "not a schizoaffective case"; 10-20 will indicate "possible schizoaffective case"; and 21 or more, will indicate "evident schizoaffective case". Higher scores indicate worsening.
Measured: Baseline (Day -1) and Day 2
Change From Baseline in Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Measured: Baseline (Day 1) and Day 2
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS is a clinical interview to assess severity and track suicidal events providing a summary of both suicidal ideation and behavior to identify the level and type of suicidality present.
Measured: Baseline (Screening - Day -21 to Day -2) and follow-up visit (11 to 13 days after final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060929
- Sponsor's protocol ID
- CR102971
- Other IDs
- ESKETINTRD1004
- Status last verified
- Mar 2014
- First submitted
- 21 Jan 2014
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device
- ClinicalTrials.gov ID
- NCT02060929
- Acronym / sponsor ID
- CR102971
- Conditions
- Healthy
- Keywords
- Healthy, Esketamine, Intranasal, Nasal Guide, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Feb 2014 (estimated)
- 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 primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine using a device with and without a nasal guide in healthy participants.
Detailed description
This is a randomized (the study medication is assigned by chance), single-center, single-dose, 2-way crossover (participants may receive different interventions sequentially during the study in 2 sequence groups), open-label (all people know the identity of the intervention) study. Approximately, 14 participants will be enrolled in this study. This study will consist of a screening phase of up to 21 days, a treatment phase of 3 days, and a follow-up phase of 9-13 days. Participants will be randomly allocated to 1 of the 2 treatment groups (Sequence 1 and 2). In sequence 1, participants will self-administer esketamine intranasally using a device with nasal guide as treatment A on Day 1 of period 1 and intranasally esketamine using a device without nasal guide as treatment B on Day 1 of period 2. In sequence 2, participants will self-administer intranasally esketamine as treatment B on Day 1 of period 1 and intranasally esketamine as treatment A on Day 1 of period 2. There will be a washout period of 5 to 10 days between each treatment regimen. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, pulse oximetry, targeted nasal examination, nasal device questionnaire, and in addition to these evaluations, specific scales will be used to assess the safety. The study duration for each participant will be approximately 45 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: EsketamineParticipants will self administer 1 spray of esketamine solution to each nostril using a intranasal (through nose) device with a nasal guide on Day 1 of period 1 as treatment regimen A at time 0 and repeated twice every 5 minutes (total dose: 84 mg). There will be a washout period of 5-10 days between the treatment regimens. On Day 1 of period 2, participants will self administer 1 spray of esketamine solution to each nostril using a intranasal device without a nasal guide as treatment regimen B at time 0 and repeated twice every 5 minutes (total dose: 84 mg). |
| Sequence 2 | Experimental | Drug: EsketamineParticipants will self administer 1 spray of esketamine solution to each nostril using a intranasal device without a nasal guide on Day 1 of period 1 as treatment regimen B at time 0 and repeated twice every 5 minutes (total dose: 84 mg). There will be a washout period of 5-10 days between the treatment regimens. On Day 1 of period 2, participants will self administer 1 spray of esketamine solution to each nostril using a intranasal device with a nasal guide as treatment regimen A at time 0 and repeated twice every 5 minutes (total dose: 84 mg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Agrees to protocol-defined use of effective contraception
- If a woman, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 of each treatment period
- Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Key exclusion criteria (5 listed)
- Current or prior history of psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
- Clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders , lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic disease, infection, hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea, myasthenia gravis, or any other illness
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study center (Day -1 of each treatment period) as deemed appropriate by the investigator
- Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, noisy breathing during sleep, facial pain, headaches, and postnasal drip
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 |
|---|---|---|
| EsketamineParticipants will self administer 1 spray of esketamine solution using a intranasal device with a nasal guide in Treatment A regimen and without nasal guide inTreatment B regimen at time 0 and repeated twice every 5 minutes (total dose: 84 mg). | Drug | Sequence 1, Sequence 2 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Cmax is defined as maximum observed analyte concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration
Elimination Half-Life Period (T1/2) of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
First-order Rate Constant of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
First-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Relative Bioavailability (Frel) of Esketamine
Time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours
Relative bioavailability is the percentage of the administered dose that is systemically available.
Change From Baseline in Clinician-Administered Dissociative States Scale (CADSS) Score
Time frame: Baseline (Day -1) and Day 2
The CADSS is a clinician administered rating scale designed to measure dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: depersonalization, derealization and amnesia. Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely). Higher scores indicate worsening.
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Score
Time frame: Baseline (Day -1) and Day 2
The BPRS is used for the measurement of psychiatric symptoms. The BPRS is an 18 item questionnaire and each question is rated on a 7-point scale ranging from 1 (not present) to 7 (extremely severe). The total score for the 18 question will be calculated by adding score of each question. The interpretation of the total scores are: 0-9 will indicate "not a schizoaffective case"; 10-20 will indicate "possible schizoaffective case"; and 21 or more, will indicate "evident schizoaffective case". Higher scores indicate worsening.
Change From Baseline in Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score
Time frame: Baseline (Day 1) and Day 2
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline (Screening - Day -21 to Day -2) and follow-up visit (11 to 13 days after final dose)
The C-SSRS is a clinical interview to assess severity and track suicidal events providing a summary of both suicidal ideation and behavior to identify the level and type of suicidality present.
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 13 Mar 2014.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 5 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 13 Mar 2014. 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 Belgium. 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?
Maximum Observed Plasma Concentration (Cmax) of Esketamine (time frame: Pre-dose, and post-dose 7, 12, 22, 32, 40, 50 minutes, 1, 1.25, 1.5, 2, 3, 4, 24 hours). The study lists 11 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 13 Mar 2014.