HealthyPhase 1NCT02857777
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese Subjects
A Phase 1 study testing Esketamine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly Japanese subjects and healthy younger adult Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy 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
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2016to 27 Jan 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A) Cohort 1: Be a Japanese man or woman greater than or equal to (>=) 65 years of age with at least 4 subjects >= 70 years of age, who was born in Japan, who has resided outside of Japan for >= 10 years, with parents and maternal and paternal grandparents who are of Japanese ethnicity. Subjects must be either healthy or present with stable, well-controlled, chronic conditions which frequently occur in the elderly, such as: Hyperlipidemia,Controlled hypertension, Impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes mellitus controlled with diet, and/or metformin monotherapy, dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy or a combination of metformin and DPP-4 inhibitor, who have glycated hemoglobin (HbA1c) levels <8 percent (%), Degenerative joint disorders and osteoporosis; B) Cohort 2: Be a healthy Japanese man or woman 20 to 55 years of age, inclusive, who was born in Japan, who has resided outside of Japan for >= 10 years, and has parents and maternal and paternal grandparents who are of Japanese ethnicity. Each subject will be matched to an elderly subject in Cohort 1 by gender and body weight (+/- 20%) using data collected during Screening
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Cohort 2: If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the treatment period. Women using contraceptives must agree to use an additional birth control method during the study and for 1 month after receiving the last dose of study drug
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
Who cannot join
- Current significant psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
- 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), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results. Elderly subjects in Cohort 1 with stable, well-controlled, chronic conditions which frequently occur in the elderly as outlined in Inclusion Criteria 1 will be permitted to participate in the study
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1 of Period 1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or before the first study drug administration as deemed appropriate by the investigator
- History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -1 of the treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Elderly (>=65 Years of Age) Japanese, and Healthy Younger Adult Japanese Subjects (20 to 55 Years of Age, Inclusive)
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly Japanese subjects and healthy younger adult Japanese subjects.
- Conditions
- Healthy
- Being tested
- Esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Subjects will self-administer intranasal esketamine as per the treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Japanese elderly subjects (Esketamine) | Experimental | Subjects will receive Treatment A (28 milligram [mg] of esketamine, administered as 1*14 mg spray of esketamine in each nostril at Time 0) in Period 1, Treatment B (56 mg of esketamine, administered as 1*14 mg spray of esketamine in each nostril at Time 0 and 5 minutes) in Period 2 and then Treatment C (84 mg of esketamine, administered as 1*14 mg spray of esketamine in each nostril at Time 0, 5, and 10 minutes) in Period 3. A washout period of 5 to 14 days will separate each intranasal esketamine treatment regimen. Receives: Drug: Esketamine |
| Cohort 2: Japanese healthy subjects (Esketamine) | Active comparator | Subjects will receive Treatment A in Period 1, Treatment B in Period 2 and then Treatment C in Period 3. A washout period of 5 to 14 days will separate each intranasal esketamine treatment regimen. Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum plasma concentration.
Measured: up to Day 2
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 hours (AUC [0-12])
The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: up to Day 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: up to Day 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: up to Day 2
Terminal Half-Life(t[1/2])
Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z).
Measured: up to Day 2
Lambda(z)
Lambda(z) is the 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: up to Day 2
Number of subjects with Adverse Events (AEs) as a measure of safety and tolerability
Measured: Screening up to Follow-up (63 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start9 Aug 2016
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT02857777
- Sponsor's protocol ID
- CR108213
- Other IDs
- 54135419TRD1018
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Elderly (>=65 Years of Age) Japanese, and Healthy Younger Adult Japanese Subjects (20 to 55 Years of Age, Inclusive)
- ClinicalTrials.gov ID
- NCT02857777
- Acronym / sponsor ID
- CR108213
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 5 Aug 2016 (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 study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly Japanese subjects and healthy younger adult Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Japanese elderly subjects (Esketamine) | Experimental | Drug: EsketamineSubjects will receive Treatment A (28 milligram [mg] of esketamine, administered as 1*14 mg spray of esketamine in each nostril at Time 0) in Period 1, Treatment B (56 mg of esketamine, administered as 1*14 mg spray of esketamine in each nostril at Time 0 and 5 minutes) in Period 2 and then Treatment C (84 mg of esketamine, administered as 1*14 mg spray of esketamine in each nostril at Time 0, 5, and 10 minutes) in Period 3. A washout period of 5 to 14 days will separate each intranasal esketamine treatment regimen. |
| Cohort 2: Japanese healthy subjects (Esketamine) | Active comparator | Drug: EsketamineSubjects will receive Treatment A in Period 1, Treatment B in Period 2 and then Treatment C in Period 3. A washout period of 5 to 14 days will separate each intranasal esketamine treatment regimen. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A) Cohort 1: Be a Japanese man or woman greater than or equal to (>=) 65 years of age with at least 4 subjects >= 70 years of age, who was born in Japan, who has resided outside of Japan for >= 10 years, with parents and maternal and paternal grandparents who are of Japanese ethnicity. Subjects must be either healthy or present with stable, well-controlled, chronic conditions which frequently occur in the elderly, such as: Hyperlipidemia,Controlled hypertension, Impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes mellitus controlled with diet, and/or metformin monotherapy, dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy or a combination of metformin and DPP-4 inhibitor, who have glycated hemoglobin (HbA1c) levels <8 percent (%), Degenerative joint disorders and osteoporosis; B) Cohort 2: Be a healthy Japanese man or woman 20 to 55 years of age, inclusive, who was born in Japan, who has resided outside of Japan for >= 10 years, and has parents and maternal and paternal grandparents who are of Japanese ethnicity. Each subject will be matched to an elderly subject in Cohort 1 by gender and body weight (+/- 20%) using data collected during Screening
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Cohort 2: If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of the treatment period. Women using contraceptives must agree to use an additional birth control method during the study and for 1 month after receiving the last dose of study drug
- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
Key exclusion criteria (5 listed)
- Current significant psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
- 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), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results. Elderly subjects in Cohort 1 with stable, well-controlled, chronic conditions which frequently occur in the elderly as outlined in Inclusion Criteria 1 will be permitted to participate in the study
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1 of Period 1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or before the first study drug administration as deemed appropriate by the investigator
- History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -1 of the treatment period
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 |
|---|---|---|
| EsketamineSubjects will self-administer intranasal esketamine as per the treatment regimen. | Drug | Cohort 1: Japanese elderly subjects (Esketamine), Cohort 2: Japanese healthy subjects (Esketamine) |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: up to Day 2
The Cmax is the maximum plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 hours (AUC [0-12])
Time frame: up to Day 2
The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
Time frame: up to Day 2
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: up to Day 2
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Terminal Half-Life(t[1/2])
Time frame: up to Day 2
Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z).
Lambda(z)
Time frame: up to Day 2
Lambda(z) is the 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.
Number of subjects with Adverse Events (AEs) as a measure of safety and tolerability
Time frame: Screening up to Follow-up (63 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 3 Feb 2025.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 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 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 3 Feb 2025. 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 (Cmax) (time frame: up to Day 2). The study lists 7 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 3 Feb 2025.