A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects - Evaluate the effect of intranasal esketamine on cognitive functioning

Janssen-Cilag0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月23日

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•1. Subject must be a man or woman, 18 to 49 years of age, inclusive.;2. Body mass index (BMI) (weight [kg]/height[m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 45 kg.;3. Blood pressure (after the subject is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at Screening and predose on Day 1 of Period 1. ;4. A 12-lead ECG consistent with normal cardiac conduction and function at Screening and predose on Day 1 of Period 1, including:;a. Sinus rhythm;b. Heart rate between 45 and 90 beats per minute (bpm);c. QTc interval <= 450 milliseconds (ms) ;d. QRS interval of <110 ms;e. PR interval <200 ms;f. Morphology consistent with healthy cardiac conduction and ;function;1st degree AV block is exclusionary.;5. Comfortable with self-administration of intranasal medication and able to follow instructions provided.

•1. Subject has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary.;2. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator.;3. Clinically significant abnormal physical examination, vital signs, or ECG at screening or on Day 1 of Period 1, as deemed appropriate by the investigator.;4. Anatomical or medical conditions that may impede delivery or absorption of study medication (e.g., undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis predose on Day 1 in Period 1).;5. 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, and at times has facial pain, headaches, and postnasal drip.;6. ject has a current or prior diagnosis of psychosis/psychotic disorder.;7.History of drug or alcohol abuse disorder within the past 1 year of Screening, or a reason to believe a subject has such a history.

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