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

January 31, 2019 updated by: INSYS Therapeutics Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78217
        • Worldwide Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cohort 1: Treatment Sequence A-D-C-B
Participants received Treatment A on Day 1 of Period 1, Treatment D on Day 1 of Period 2, Treatment C on Day 1 of Period 3 and Treatment B on Day 1 of Period 4.
Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
EXPERIMENTAL: Cohort 2: Treatment Sequence B-C-D-A
Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, Treatment D on Day 1 of Period 3 and Treatment A on Day 1 of Period 4.
Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
EXPERIMENTAL: Cohort 3: Treatment Sequence C-A-B-D
Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, Treatment B on Day 1 of Period 3 and Treatment D on Day 1 of Period 4.
Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
EXPERIMENTAL: Cohort 4: Treatment Sequence D-B-A-C
Participants received Treatment D on Day 1 of Period 1, Treatment B on Day 1 of Period 2, Treatment A on Day 1 of Period 3 and Treatment C on Day 1 of Period 4.
Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area Under the Curve From Time 0 to the Last Measured Concentration (AUC0-t) for Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose
AUC Extrapolated to Infinity (AUC0-inf) for Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) for Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) for Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
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
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) for Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose
Pre-dose and at multiple time points up to 24 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Concentrations of Unconjugated Naloxone
Time Frame: Pre-dose and at multiple time points up to 2 hours post-dose
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)
Time Frame: 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.
Day 1 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
INSYS Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS012-18-119

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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