Healthy VolunteersPhase 1NCT01980303
A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers
A Phase 1 study testing Esketamine in people with Healthy Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese (Cohort 1) or Caucasian (Cohort 2) man or woman, between 20 to 55 years of age
- Resided outside of Japan for no more than 5 years and have parents and maternal and paternal grandparents who are of Japanese ethnicity
- Blood pressure (after the participant is in the supine position for 5 minutes) between 90 and 145 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration
- Comfortable with self-administration of intranasal medication and able to follow instructions provided
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); hypertension or vascular disorders; significant pulmonary disease, including any bronchospastic respiratory disease; diabetes mellitus; renal or hepatic insufficiency; thyroid disease; neurologic or psychiatric disease, infection; kidney/urinary tract disturbances; sleep apnea, or myasthenia gravis, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center
- Anatomical or medical conditions that may impede delivery or absorption of study medication
- 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, and at times has facial pain, headaches, and postnasal drip
- Has a current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders; mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or chronic fatigue syndrome; generalized anxiety disorder, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Subjects
The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants.
Read the detailed description
This is an open-label single-center study with 2 cohorts (groups). The study will consist of a screening phase, a treatment phase, and a follow-up visit (9 to 13 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria. A target of 14 healthy Japanese and 14 healthy Caucasian adult participants (20 to 55 years of age inclusive) will be enrolled in Cohort 1 and Cohort 2, respectively.
The participants in each cohort will self-administer each of the 3 different single-dose regimens of intranasal esketamine (Treatments A, B, and C) over the 3 treatment periods (ie, 1 treatment per period) in an open-label manner (both the investigator and the participant knows which intervention the participant receives). The participants will be randomly (like the toss of a coin) assigned to receive Treatment A and Treatment B in the first two periods (ie, Treatment A in Period 1 and Treatment B in Period 2, or the reverse order). All participants will receive Treatment C in Period 3. The regimens differ in the number of sprays to achieve the total dose and the total esketamine dose administered.
Safety and tolerability will be evaluated throughout the study and will include assessment of adverse events, targeted nasal examinations, laboratory tests, electrocardiogram, physical examination, pulse oximetery, and vital signs.
- Conditions
- Healthy Volunteers
- Being tested
- Esketamine
- Keywords
- Healthy, Japanese, Caucasian, Anesthetics, Intranasal, Esketamine, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Fourteen percent esketamine solution (14 mg of esketamine per 100 microliter) will be administered intranasally by nasal spray pump.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Treatment A | Experimental | Japanese participants will receive 1 spray of esketamine solution in each nostril (total dose: 28 mg). Receives: Drug: Esketamine |
| Cohort 1: Treatment B | Experimental | Japanese participants will receive 1 spray of esketamine solution in each nostril at time 0 and 5 minutes (total dose: 56 mg). Receives: Drug: Esketamine |
| Cohort 1: Treatment C | Experimental | Japanese participants will receive 1 spray of esketamine solution in each nostril at time 0, 5, and 10 minutes (total dose: 84 mg). Receives: Drug: Esketamine |
| Cohort 2: Treatment A | Experimental | Caucasian participants will receive 1 spray of esketamine solution in each nostril (total dose: 28 mg). Receives: Drug: Esketamine |
| Cohort 2: Treatment B | Experimental | Caucasian participants will receive 1 spray of esketamine solution in each nostril at time 0 and 5 minutes (total dose: 56 mg). Receives: Drug: Esketamine |
| Cohort 2: Treatment C | Experimental | Caucasian participants will receive 1 spray of esketamine solution in each nostril at time 0, 5 and 10 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 plasma concentration during a dosing interval (Cmax) of esketamine and noresketamine
Measured: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Time to reach the maximum plasma concentration (tmax) of esketamine and noresketamine
Measured: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Area under the plasma concentration-time curve from Time 0 to time of the last quantifiable concentration of esketamine and noresketamine
Measured: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Elimination half-life of esketamine and noreskatamine
Measured: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Area under the plasma concentration-time curve from time 0 to infinite time in which Clast is the last observed quantifiable concentration of esketamine and noresketamine
Measured: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Secondary outcomes (1)
The number of volunteers who experience adverse events as a measure of safety and tolerability.
Measured: Up to 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- 29 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
- NCT01980303
- Sponsor's protocol ID
- CR101101
- Other IDs
- ESKETINTRD1002
- Status last verified
- Jan 2014
- First submitted
- 4 Nov 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.
PubMed 33128208
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01980303
- Acronym / sponsor ID
- CR101101
- Conditions
- Healthy Volunteers
- Keywords
- Healthy, Japanese, Caucasian, Anesthetics, Intranasal, Esketamine, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Nov 2013 (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 purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants.
Detailed description
This is an open-label single-center study with 2 cohorts (groups). The study will consist of a screening phase, a treatment phase, and a follow-up visit (9 to 13 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria. A target of 14 healthy Japanese and 14 healthy Caucasian adult participants (20 to 55 years of age inclusive) will be enrolled in Cohort 1 and Cohort 2, respectively.
The participants in each cohort will self-administer each of the 3 different single-dose regimens of intranasal esketamine (Treatments A, B, and C) over the 3 treatment periods (ie, 1 treatment per period) in an open-label manner (both the investigator and the participant knows which intervention the participant receives). The participants will be randomly (like the toss of a coin) assigned to receive Treatment A and Treatment B in the first two periods (ie, Treatment A in Period 1 and Treatment B in Period 2, or the reverse order). All participants will receive Treatment C in Period 3. The regimens differ in the number of sprays to achieve the total dose and the total esketamine dose administered.
Safety and tolerability will be evaluated throughout the study and will include assessment of adverse events, targeted nasal examinations, laboratory tests, electrocardiogram, physical examination, pulse oximetery, and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Treatment A | Experimental | Drug: EsketamineJapanese participants will receive 1 spray of esketamine solution in each nostril (total dose: 28 mg). |
| Cohort 1: Treatment B | Experimental | Drug: EsketamineJapanese participants will receive 1 spray of esketamine solution in each nostril at time 0 and 5 minutes (total dose: 56 mg). |
| Cohort 1: Treatment C | Experimental | Drug: EsketamineJapanese participants will receive 1 spray of esketamine solution in each nostril at time 0, 5, and 10 minutes (total dose: 84 mg). |
| Cohort 2: Treatment A | Experimental | Drug: EsketamineCaucasian participants will receive 1 spray of esketamine solution in each nostril (total dose: 28 mg). |
| Cohort 2: Treatment B | Experimental | Drug: EsketamineCaucasian participants will receive 1 spray of esketamine solution in each nostril at time 0 and 5 minutes (total dose: 56 mg). |
| Cohort 2: Treatment C | Experimental | Drug: EsketamineCaucasian participants will receive 1 spray of esketamine solution in each nostril at time 0, 5 and 10 minutes (total dose: 84 mg). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Japanese (Cohort 1) or Caucasian (Cohort 2) man or woman, between 20 to 55 years of age
- Resided outside of Japan for no more than 5 years and have parents and maternal and paternal grandparents who are of Japanese ethnicity
- Blood pressure (after the participant is in the supine position for 5 minutes) between 90 and 145 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
- Smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); hypertension or vascular disorders; significant pulmonary disease, including any bronchospastic respiratory disease; diabetes mellitus; renal or hepatic insufficiency; thyroid disease; neurologic or psychiatric disease, infection; kidney/urinary tract disturbances; sleep apnea, or myasthenia gravis, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center
- Anatomical or medical conditions that may impede delivery or absorption of study medication
- 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, and at times has facial pain, headaches, and postnasal drip
- Has a current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders; mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or chronic fatigue syndrome; generalized anxiety disorder, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa
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 |
|---|---|---|
| EsketamineFourteen percent esketamine solution (14 mg of esketamine per 100 microliter) will be administered intranasally by nasal spray pump. | Drug | Cohort 1: Treatment A, Cohort 1: Treatment B, Cohort 1: Treatment C, Cohort 2: Treatment A, Cohort 2: Treatment B, Cohort 2: Treatment C |
Primary outcome
Maximum plasma concentration during a dosing interval (Cmax) of esketamine and noresketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Time to reach the maximum plasma concentration (tmax) of esketamine and noresketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Area under the plasma concentration-time curve from Time 0 to time of the last quantifiable concentration of esketamine and noresketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Elimination half-life of esketamine and noreskatamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
Area under the plasma concentration-time curve from time 0 to infinite time in which Clast is the last observed quantifiable concentration of esketamine and noresketamine
Time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours
1 secondary outcome
The number of volunteers who experience adverse events as a measure of safety and tolerability.
Time frame: Up to 71 days
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 28 Jan 2014.
- Derived from this study: PubMed 33128208Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.
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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 Volunteers, run by Janssen Research & Development, LLC at 1 site in United States.
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 6 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 28 Jan 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 United States. 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 plasma concentration during a dosing interval (Cmax) of esketamine and noresketamine (time frame: Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980303, which also lists 1 linked publication.
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 28 Jan 2014.