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

Allergic Rhinitis Clinical Trial

Official title: An Open-label Study to Assess the Effects of Allergic Rhinitis and Coadministration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a Phase 1, single-center, open -label (all people know the identity of the intervention) study of intranasal esketamine in two cohorts: Cohort 1 will be healthy participants assigned to a fixed treatment sequence and Cohort 2 will be participants with nasal rhinitis randomized to 1 of 2 treatment sequences. For all participants, the study comprises 3 phases: a Screening phase (up to 21 days), an Open Label Treatment phase (includes 2 treatment periods; Period 1 and Period 2) and Follow-up phase (10 +/-2 days after last dose of esketamine).

Total study duration for participants in Cohort 1 is up to 52 days which includes Screening phase, Period 1 (3 days) where participants will self-administer a 56 milligram (mg) intranasal dose of esketamine solution on Day 1 and Period 2 (16 days) where participants will self-administer 200 microgram (mcg) of intranasal mometasone suspension on Day 1 (which will begin immediately following the 30 hour pharmacokinetic sample of Period 1) to Day 15, and then 200 mcg of intranasal mometasone suspension prior to a 56 mg dose of intranasal esketamine solution on Day 16 and the follow-up phase. Total study duration for participants in Cohort 2 is up to 44 days which includes Screening phase, Period 1 and Period 2 each of 3 days with a washout period of 5 to 10 days in-between esketamine dosing, and the follow-up phase. Cohort 2 participants will be randomly assigned to either treatment Sequence 1 or 2, wherein Sequence 1 comprises a 56 mg intranasal dose of esketamine solution alone in period 1 followed by period 2 which comprises a pretreatment with oxymetazoline 0.05 percent (%) weight by volume (w/v) solution 1 hour before administration of a 56 mg intranasal dose of esketamine solution. Sequence 2 comprises of a pretreatment with oxymetazoline 0.05 % w/v solution 1 hour before administration of a 56 mg intranasal dose of esketamine solution in Period 1 followed by period 2 which comprises a 56 mg intranasal dose of esketamine solution alone. Blood samples will be collected for evaluation of pharmacokinetic parameters of intranasal esketamine in healthy participants and participants with allergic rhinitis. Participants' safety will be monitored throughout the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

• NCT number: NCT02154334
• Study type: Interventional
• Source: Janssen Research & Development, LLC
• Status: Completed
• Phase: Phase 1
• Start date: June 2014
• Completion date: October 2014