Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms affecting the nose) and co-administration of mometasone or oxymetazoline on the pharmacokinetics (explores what the body does to the drug), safety, and tolerability of intranasal (administered through the nose) esketamine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Esketamine; Mometasone Furoate; Oxymetazoline; Pharmaceutical Solutions; Phenylephrine

Criteria

Inclusion Criteria:

• Female participant must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent (abstinence is an acceptable means of birth control only if it is already established as the participant's usual and preferred lifestyle), or, if sexually active, be practicing an effective method of birth control (for example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study

• Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg)

• Systolic blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) (inclusive) and diastolic blood pressure not more than 90 mmHg

• Comfortable with self-administration of intranasal medication and able to follow instructions provided

• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function

• For Cohort 2, participants should have a history of allergic rhinitis and a positive prick test for grass pollen at screening

• For Cohort 2, participants must have a Total Nasal Symptoms Score (TNSS) greater than or equal to (>=) 6 with a nasal congestion score of >=2 (minimum for "moderate rhinitis") on at least one occasion while participants are in the ECC during screening

Exclusion Criteria:

• Current significant psychiatric (mental disorders) disorder including but not limited to psychotic (a person exhibiting mental illness), bipolar, major depressive or anxiety disorder

• Clinically significant medical illness including (but not limited to) cardiac arrhythmias (irregular heart beat) or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias [disorder of blood]), lipid abnormalities, significant pulmonary (having to do with the lungs) disease, including bronchospastic respiratory disease, diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects), renal or hepatic insufficiency, thyroid disease, neurologic disease, infection, hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea (breathing problems while sleeping), myasthenia gravis (disorder that causes muscles to get tired quickly), or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• Use of any prescription or nonprescription medication, within 14 days before the first scheduled dose of the study drug

• Anatomical or medical conditions that may delay delivery or absorption of study medication (for example. undergone facial reconstructions, structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions [any visible local abnormality of the tissues of the skin] of the nostrils or nasal passages; undergone sinus [a depression or cavity formed by a bending or curving] surgery in the previous 2 years; or signs and symptoms of upper respiratory infection, rhinitis [Cohort 1 only], active allergies [Cohort 1 only], or has a history of frequent sinus infections or complications)

• Has an abnormal or deviated nasal septum (when the inner wall separating the two sides of the nose is off to one side) 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, noisy breathing during sleep, facial pain, headaches, and postnasal drip