Overview
A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2014-08-01
2014-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to assess the cognitive effects associated with administration of intranasal esketamine 84 mg.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
Esketamine
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