Recruitment

Recruitment Status
Completed

Inclusion Criteria

Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
...
Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
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

Exclusion Criteria

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
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
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 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

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

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...

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.

Inclusion Criteria

Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
...
Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
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

Exclusion Criteria

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
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
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 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

Tracking Information

NCT #
NCT02060929
Collaborators
Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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