Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • 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
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Vince and Associates Clinical Research, Inc.

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

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Please contact site for more information

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
Intervention / Treatment
EXPERIMENTAL: 4mg Intranasal Naltrexone
Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril
Drug: Naltrexone
EXPERIMENTAL: 4mg Intranasal Naltrexone with Intravail
Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
Drug: Naltrexone
Other: Intravail
EXPERIMENTAL: 2mg Intramuscular Naltrexone
Administer 2 mg formulation intramuscularly
Drug: Naltrexone
EXPERIMENTAL: 50mg Naltrexone
Administer 50mg formulation orally
Drug: Naltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration (Cmax)
Time Frame: 48 hours
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)
Time Frame: 48 hours
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)
Time Frame: 48 hours
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)
Time Frame: 48 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Maximum of 18 days
Will be reported from the start of the first session to follow-up visit
Maximum of 18 days
Vital Signs
Time Frame: 12 days
Measured before and after naltrexone administration
12 days
12-lead electrocardiogram
Time Frame: 12 days
Measured before and after naltrexone administration
12 days
Nasal Irritation Scoring
Time Frame: 5 days
Will be reported from the start of the first session to follow-up visit
5 days

Collaborators and Investigators

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

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Study Chair: Nora Chiang, PhD, National Institute on Drug Abuse (NIDA)

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

July 1, 2016

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (ESTIMATE)

April 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Naltexone-Ph1a-002

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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