A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Esketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094378

CR103823

2014-000468-16 (EudraCT Number)

ESKETINTRD1005 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the cognitive effects associated with administration of intranasal esketamine 84 mg.

Full description

This is a randomized (participants assigned to 1 of 2 treatment sequences by chance), double-blind (identity of study drugs will not be known to participant or members of study staff), placebo-controlled (a substance without active drug identical in appearance to esketamine), 2-period crossover study (participants assigned to each treatment sequence will receive 1 dose of esketamine and 1 dose of placebo administered intranasally [through the nose]) conducted in healthy adult participants at a single center. Participants will complete 3 study phases: A screening phase of up to 3 weeks; a 2-week double-blind treatment phase, which includes 2 treatment periods (Periods 1 and 2) separated by a washout interval of at least 7 days; and, a 1-week posttreatment (follow up) phase, if applicable. The duration of the study for each participant will be approximately 6 weeks. Blood and urine samples will be collected during the study for laboratory assessments. Participants will be monitored for safety from the time of signing the informed consent form up until 1 week after the last dose of study drug (or end of treatment).

Enrollment: 24 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Esketamine-Placebo

Experimental group

Description:

Participants assigned to treatment sequence 1 will receive 84 mg esketamine intranasally on Day 1 of Period 1 and then receive placebo intranasally on Day 1 in Period 2. Periods 1 and 2 will be separated by 7 days.

Treatment:

Drug: Esketamine

Drug: Placebo

Placebo-Esketamine

Placebo Comparator group

Description:

Participants assigned to treatment sequence 2 will receive placebo intranasally on Day 1 of Period 1 and then receive 84 mg esketamine intranasally on Day 1 in Period 2. Periods 1 and 2 will be separated by 7 days.

Treatment:

Drug: Esketamine

Drug: Placebo