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

Primary Purpose

Opioid-Related Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Naltrexone

Intravail

About this trial

This is an interventional treatment trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vince and Associates Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

4mg Intranasal Naltrexone

4mg Intranasal Naltrexone with Intravail

2mg Intramuscular Naltrexone

50mg Naltrexone

Arm Description

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

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

Administer 2 mg formulation intramuscularly

Administer 50mg formulation orally

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

Adverse Events

Will be reported from the start of the first session to follow-up visit

Vital Signs

Measured before and after naltrexone administration

12-lead electrocardiogram

Measured before and after naltrexone administration

Nasal Irritation Scoring

Will be reported from the start of the first session to follow-up visit

Full Information

NCT ID

NCT02750748

First Posted

April 21, 2016

Last Updated

January 11, 2017

Sponsor

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT02750748

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4mg Intranasal Naltrexone

Arm Type

Experimental

Arm Description

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

Arm Title

4mg Intranasal Naltrexone with Intravail

Arm Type

Experimental

Arm Description

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

Arm Title

2mg Intramuscular Naltrexone

Arm Type

Experimental

Arm Description

Administer 2 mg formulation intramuscularly

Arm Title

50mg Naltrexone

Arm Type

Experimental

Arm Description

Administer 50mg formulation orally

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Intervention Type

Other

Intervention Name(s)

Intravail

Primary Outcome Measure Information:

Title

Plasma Concentration (Cmax)

Description

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

Time Frame

48 hours

Title

Plasma Concentration (Tmax)

Description

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

Time Frame

48 hours

Title

Plasma Concentration (AUC 0-t)

Description

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

Time Frame

48 hours

Title

Plasma Concentration (AUC 0-inf)

Description

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

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Will be reported from the start of the first session to follow-up visit

Time Frame

Maximum of 18 days

Title

Vital Signs

Description

Measured before and after naltrexone administration

Time Frame

12 days

Title

12-lead electrocardiogram

Description

Measured before and after naltrexone administration

Time Frame

12 days

Title

Nasal Irritation Scoring

Description

Will be reported from the start of the first session to follow-up visit

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nora Chiang, PhD

Organizational Affiliation

National Institute on Drug Abuse (NIDA)

Official's Role

Study Chair

Facility Information:

Facility Name

Vince and Associates Clinical Research, Inc.

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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