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

Healthy

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source