NCT03827629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2017

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

9 days

First QC Date

January 31, 2019

Last Update Submit

January 31, 2019

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • Plasma Concentration of Unconjugated Naloxone

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

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

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

Secondary Outcomes (11)

  • 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

  • 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

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

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

  • Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone

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

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

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

  • +6 more secondary outcomes

Study Arms (6)

Cohort 1: Treatment Sequence A-B-C

EXPERIMENTAL

Participants received Treatment A on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment C on Day 1 of Period 3.

Drug: Treatment A: Naloxone Nasal SprayDrug: Treatment B: Naloxone Nasal SprayDrug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

Cohort 2: Treatment Sequence B-C-A

EXPERIMENTAL

Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment A on Day 1 of Period 3.

Drug: Treatment A: Naloxone Nasal SprayDrug: Treatment B: Naloxone Nasal SprayDrug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

Cohort 3: Treatment Sequence C-A-B

EXPERIMENTAL

Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment B on Day 1 of Period 3.

Drug: Treatment A: Naloxone Nasal SprayDrug: Treatment B: Naloxone Nasal SprayDrug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

Cohort 4: Treatment Sequence A-C-B

EXPERIMENTAL

Participants received Treatment A on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment B on Day 1 of Period 3.

Drug: Treatment A: Naloxone Nasal SprayDrug: Treatment B: Naloxone Nasal SprayDrug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

Cohort 5: Treatment Sequence C-B-A

EXPERIMENTAL

Participants received Treatment C on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment A on Day 1 of Period 3.

Drug: Treatment A: Naloxone Nasal SprayDrug: Treatment B: Naloxone Nasal SprayDrug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

Cohort 6: Treatment Sequence B-A-C

EXPERIMENTAL

Participants received Treatment B on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment C on Day 1 of Period 3.

Drug: Treatment A: Naloxone Nasal SprayDrug: Treatment B: Naloxone Nasal SprayDrug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

Interventions

Treatment A: Naloxone Nasal SprayDRUG

Participants received naloxone nasal spray following a 10 hour fast.

Cohort 1: Treatment Sequence A-B-CCohort 2: Treatment Sequence B-C-ACohort 3: Treatment Sequence C-A-BCohort 4: Treatment Sequence A-C-BCohort 5: Treatment Sequence C-B-ACohort 6: Treatment Sequence B-A-C
Treatment B: Naloxone Nasal SprayDRUG

Participants received naloxone nasal spray following a 10 hour fast.

Cohort 1: Treatment Sequence A-B-CCohort 2: Treatment Sequence B-C-ACohort 3: Treatment Sequence C-A-BCohort 4: Treatment Sequence A-C-BCohort 5: Treatment Sequence C-B-ACohort 6: Treatment Sequence B-A-C
Treatment C: Naloxone HCL Intramuscular (IM) InjectionDRUG

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

Cohort 1: Treatment Sequence A-B-CCohort 2: Treatment Sequence B-C-ACohort 3: Treatment Sequence C-A-BCohort 4: Treatment Sequence A-C-BCohort 5: Treatment Sequence C-B-ACohort 6: Treatment Sequence B-A-C

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Giovanni DeCastro

    INSYS Therapeutics Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 1, 2019

Study Start

August 7, 2017

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(1)