A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.

Key facts

Study ID

NCT03827629

Run by

INSYS Therapeutics Inc

People needed

24

Starts

2017-08-07

Expected to finish

2017-08-16

Last updated by the study team

2019-02-01

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A minimum body weight of 50 kg and a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2)
• A seated blood pressure between 90 and 140 millimeters of mercury (mmHg) systolic/50 and 90 mmHg diastolic (inclusive)
• Female subjects had a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening

You may not qualify if…

• A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients.
• Any documented clinically significant infection, injury, or illness within 1 month prior to screening.
• An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening.
• A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening. Alcohol abuse was defined as greater than 14 drinks per week.
• Positive serology test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
• A positive urine test result for alcohol, drugs, or cotinine at screening or check-in.
• A condition that the Investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk.
• Used any opioids for 30 days prior to Day 1.
• Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
• Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestion.

Where it is running

• Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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