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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827629
• Other study ID #: INS012-17-108
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2017
• Est. completion date: August 16, 2017

Study information

• Verified date: January 2019
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 ß-human chorionic gonadotropin (ß-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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
• Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
• Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Unconjugated Naloxone		Pre-dose and at multiple time points up to 1 hour post-dose
Primary	Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 1 hour post-dose
Secondary	Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Area Under the Curve from Time 0 to Infinity (AUC0-inf) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Last Quantifiable Concentration (Clast) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Time of the Last Quantifiable Concentration (Tlast) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Elimination Rate Constant (?z) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Elimination Half-Life (t1/2) of Unconjugated Naloxone		Pre-dose and at multiple time points up to 24 hours post-dose
Secondary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Day 1 up to Day 10