NCT02750748

Brief Summary

To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2016

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

First Submitted

Initial submission to the registry

April 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

April 21, 2016

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Outcome Measures

Primary Outcomes (4)

  • Plasma Concentration (Cmax)

    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

    48 hours

  • Plasma Concentration (Tmax)

    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

    48 hours

  • Plasma Concentration (AUC 0-t)

    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

    48 hours

  • Plasma Concentration (AUC 0-inf)

    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

    48 hours

Secondary Outcomes (4)

  • Adverse Events

    Maximum of 18 days

  • Vital Signs

    12 days

  • 12-lead electrocardiogram

    12 days

  • Nasal Irritation Scoring

    5 days

Study Arms (4)

4mg Intranasal Naltrexone

EXPERIMENTAL

Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril

Drug: Naltrexone

4mg Intranasal Naltrexone with Intravail

EXPERIMENTAL

Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril

Drug: NaltrexoneOther: Intravail

2mg Intramuscular Naltrexone

EXPERIMENTAL

Administer 2 mg formulation intramuscularly

Drug: Naltrexone

50mg Naltrexone

EXPERIMENTAL

Administer 50mg formulation orally

Drug: Naltrexone

Interventions

NaltrexoneDRUG
2mg Intramuscular Naltrexone4mg Intranasal Naltrexone4mg Intranasal Naltrexone with Intravail50mg Naltrexone
IntravailOTHER
4mg Intranasal Naltrexone with Intravail

Eligibility Criteria

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

You may qualify if:

  • Males and females 18 to 55 years of age, inclusive.
  • Provide written informed consent.
  • BMI ranging from 18 to 30 kg/m2, inclusive.
  • Adequate venous access.
  • No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
  • Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. Oral contraceptives are prohibited.
  • Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice.
  • Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

You may not qualify if:

  • Please contact site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nora Chiang, PhD

    National Institute on Drug Abuse (NIDA)

    STUDY CHAIR

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

April 21, 2016

First Posted

April 25, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)