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Completed

NCT Number: NCT03827629

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Treatment A: Naloxone Nasal Spray

Drug

Participants received naloxone nasal spray following a 10 hour fast.

Treatment B: Naloxone Nasal Spray

Drug

Participants received naloxone nasal spray following a 10 hour fast.

Treatment C: Naloxone HCL Intramuscular (IM) Injection

Drug

Participants received naloxone HCl IM injection following a 10 hour fast.

Primary outcomes

  1. Plasma Concentration of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 1 hour post-dose

  2. Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 1 hour post-dose

Secondary outcomes

  1. Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  2. Area Under the Curve from Time 0 to Infinity (AUC0-inf) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  3. Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  4. Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  5. Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  6. Last Quantifiable Concentration (Clast) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  7. Time of the Last Quantifiable Concentration (Tlast) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  8. Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  9. Elimination Rate Constant (λz) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  10. Elimination Half-Life (t1/2) of Unconjugated Naloxone

    Time frame: Pre-dose and at multiple time points up to 24 hours post-dose

  11. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 10

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A serious AE (SAE) is any AE that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention.

Sponsors and collaborators

Lead sponsor

INSYS Therapeutics Inc

Industry

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Crossover, Comparative Bioavailability Study of Naloxone Nasal Spray and Naloxone Hydrochloride Intramuscular Injection in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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