CompletedPhase 1ketamine
A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects
Sponsored by Janssen Research & Development, LLC
NCT ID
NCT02094378
Target Enrollment
24 participants
Start Date
2014-06
Est. Completion
2014-08
About This Study
The purpose of this study is to assess the cognitive effects associated with administration of intranasal esketamine 84 mg.
Conditions Studied
Interventions
- •Esketamine
- •Placebo
Eligibility
Age:18 Years - 49 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria: * Body mass index (BMI) (weight \[kg\]/height\[m2\]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 45 kg * 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 * A 12-lead ECG consistent with normal cardiac conduction and function at Screening and predose on Day 1 of Period 1 * Comfortable with self-administration of intranasal medication and able to follow instructions provided * Non-smoker for at least 6 months before first study drug administration Exclusion Criteria: * 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 * Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or on Day 1 of Period 1, as deemed appropriate by the investigator * Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or on Day 1 of Period 1, as deemed appropriate by the investigator * 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 of Period 1) * 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
Study Locations (1)
Leiden, Netherlands