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

Phase 1

Completed

• Conditions: Healthy Volunteer

• Registration Number: NCT03827642
• Lead Sponsor: INSYS Therapeutics Inc

Brief Summary

The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-23
• Primary Completion: 2018-05-06
• Study Completion: 2018-05-06
• Status Verified: 2019-01
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• A minimum body weight of 50 kg. Body mass index (BMI) between 18.0 and 32.0 kg/m2
• A seated blood pressure between 90 and 140 mmHg systolic/50 and 90 mmHg diastolic
• 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
• 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 congestions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time 0 to the Last Measured Concentration (AUC0-t) for Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
AUC Extrapolated to Infinity (AUC0-inf) for Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) for Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) for Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) for Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) for Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone	Pre-dose and at multiple time points up to 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Plasma Concentrations of Unconjugated Naloxone	Pre-dose and at multiple time points up to 2 hours post-dose
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 to Day 14	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.

Trial Locations

Locations (1)

Worldwide Clinical Trials; 🇺🇸 San Antonio, Texas, United States