Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

Exclusion Criteria

• •Participants planning to become pregnant during the study or currently breastfeeding.
• •Any acute condition, in the opinion of the Investigator, that is not fully resolved at least 4 weeks prior to baseline.
• •Participant has a deviated septum, previous rhinoplasty, abnormal nasal anatomy, other nasal symptoms (i.e., blocked and/or runny nose), or other nasal surgeries (i.e., polyp removal) within 1 year, or needs to use another nasal spray product during study.
• •Participant with current upper respiratory infection (URI) or has had URI within 7 days prior to screening.
• •Subject has had an episode of epistaxis within 30 days prior screening or has experienced recurrent episodes of epistaxis within 1 year prior to screening.
• •Participant has used any prescription or nonprescription drugs/supplements with increased risk of bleeding within 28 days or 5 half-lives (whichever is longer) or complementary and alternative medicines within 28 days before the first dose of study drug with exception of oral contraceptives. All other prescription medications, over-the-counter, and natural health products within 14 days or 5 half-lives prior to the first dosing.
• •Participant is currently participating in another clinical study of an investigational drug or has been dosed with any investigational drug within 30 days or 5 half-lives (whichever is longer) of the compound.
• •Had a history of abuse or current misuse of illicit drugs, alcohol, or tobacco:
• •1. alcohol abuse (regularly drinks more than 14 units of alcohol per week; 1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of spirit \[40% a/v\]) or history of alcohol abuse within 6 months prior to Screening
• •2. positive for recent alcohol use (by breathalyzer) at Screening or Baseline (Day -1)
• •3. a history or evidence of abuse of licit or illicit drug substances or a positive urine drug screen (a urine sample was obtained for testing to determine the presence or absence of Schedule 1 or Schedule 2 typical drugs of abuse or their metabolites, including opioids, amphetamine derivatives, cocaine, and other analytes as needed) or drugs of abuse prior to Screening. History of cannabinoid use within 1 year prior to Screening or any current evidence of abuse.
• •4. use of tobacco-containing products or had a history of tobacco use within 1 year prior to the screening visit
• •5. use of e-cigarettes and/or nicotine replacement products or had used these products within 1 year prior to the screening visit.
• •Participant who had consumed xanthine containing products (e.g., tea, coffee, cola), caffeine, within 24 hours of check-in. Participants had to refrain from ingesting these throughout the study
• •History of severe allergic reaction or anaphylaxis to any component of the investigational product
• •Participant had a positive test result at Screening for human immunodeficiency virus (HIV) 1 or 2 antibody, hepatitis C virus antibodies, or hepatitis B surface antigen
• •Participant was unable or unwilling to undergo venipuncture for blood sample collection because of poor tolerability or unlikely to complete the trial due to poor venous access
• •Participant who had donated plasma or whole blood within 30 days and 60 days, respectively, prior to dosing
• •On standard 12-lead ECG, a corrected QT interval using the Fredericia formula (QTcF) interval \>450 msec for males and females. If a single ECG QTcF is \>450, two more ECGs were obtained over a 5-10 min period and the average of the QTcF interval from the 3 ECGs readings were to be used to determine eligibility
• •Planned medical or surgical procedure that could have adversely impact the participant's participation or the conduct of the study
• •Any disease, including serious medical or psychiatric condition and/or clinically significant abnormality of laboratory parameters and/or any other reason, which in the opinion of the Investigator and/or medical monitor (MM) compromised the safety of the participant or integrity of the study, interfered with the participant participation in the trial, or compromised the trial objectives
• •Participant had a B-SIT score outside of the normative range (10-12) at screening.