NCT02572089

Brief Summary

To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1

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

October 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

October 5, 2015

Last Update Submit

January 11, 2017

Conditions

Drug OverdoseOpioid-Related Disorders

Outcome Measures

Primary Outcomes (5)

  • Maximum Plasma Concentration (Cmax)

    Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration.

    720 minutes

  • Time at Maximum Plasma Concentration (Tmax)

    Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration

    720 minutes

  • Area Under the Concentration (AUC 0-t)

    Time curve from time zero to last measurable concentration. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration

    720 minutes

  • Area Under Curve (AUC 0-inf)

    Time curve from time zero to infinity. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration

    720 minutes

  • Half-life

    The apparent terminal exponential half-life. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration

    720 minutes

Secondary Outcomes (4)

  • Adverse events

    minimum of 18 days

  • Vital Signs

    480 minutes

  • 12-lead electrocardiogram

    480 minutes

  • Nasal Irritation Scoring

    24 hours

Study Arms (5)

2mg Intranasal Naloxone

EXPERIMENTAL

Administer 0.1mL spray of the 20 mg/mL formulation in one nostril

Drug: Naloxone

4mg(a) Intranasal Naloxone

EXPERIMENTAL

Administer 0.1mL spray of the 20 mg/mL formulation in both nostrils

Drug: Naloxone

4mg(b) Intranasal Naloxone

EXPERIMENTAL

Administer 0.1mL spray of the 40mg/mL formulation in one nostril

Drug: Naloxone

8mg Intranasal Naloxone

EXPERIMENTAL

Administer 0.1mL spray of the 40mg/mL formulation in both nostrils

Drug: Naloxone

Intramuscular Naloxone

EXPERIMENTAL

Administer 1mL of 0.4mg/mL formulation intramuscularly

Drug: Naloxone

Interventions

NaloxoneDRUG
2mg Intranasal Naloxone4mg(a) Intranasal Naloxone4mg(b) Intranasal Naloxone8mg Intranasal NaloxoneIntramuscular Naloxone

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be able to provide written consent
  • Must have a BMI ranging from 18 to 30kg/m2, inclusive
  • Must have adequate venous access
  • Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.
  • Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
  • Must agree to not ingest alcohol, drinks containing xanthine greater than 500 mg/day (e.g., Coca Cola, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

You may not qualify if:

  • Please contact clinical site directly for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vince Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Drug OverdoseOpioid-Related Disorders

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Prescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

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

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 8, 2015

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 12, 2017

Record last verified: 2015-10

Locations

US(1)