Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Esketamine; Mometasone; Oxymetazoline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will self-administer one Intranasal spray of 14 mg esketamine solution in each nostril on Day 1 at time 0 and 5 minutes (total esketamine dose will be 56 mg) in Period 1 and Period 2.; Healthy participants will self-administer 2 intranasal sprays of 50 mcg mometasone suspension in each nostril for a total dose of 200 mcg on days 1 to 15 and 2 intranasal sprays of 50 mcg mometasone suspension in each nostril prior to 1 intranasal spray of esketamine solution 14 mg in each nostril at Time 0 and 5 minutes for a total dose of 56 mg on Day 16 in Period 2.; Nasal rhinitis participants will self-administer 2 intranasal sprays of Oxymetazoline 0.05% w/v solution in each nostril at time -1 hour before administration of 1 Intranasal spray of 14 mg esketamine solution in each nostril at time 0 and 5 minutes, for a total dose of 56 mg in Period 1or Period 2.
Intervention MeSH terms: Mometasone Furoate; Phenylephrine; Oxymetazoline; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Healthy; Esketamine; Mometasone; Oxymetazoline; Phase 1