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Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Primary Purpose

Opioid-Related Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nalmefene

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
Provide written informed consent
Body Mass index (BMI) ranging from 18 to 32 kg/m2
Adequate venous access
No clinically significant concurrent medical conditions
Males subjects must agree to use an acceptable method of birth 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 subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited
Agree not to ingest alcohol, drinks containing xanthine >500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

Please contact the site for more information

Sites / Locations

Vince and Associates Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Nalmefene (high dose)

Nalmefene and Intravail

Nalmefene (low dose)

Nalmefene Intramuscular

Arm Description

Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period

Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period

Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period

Nalmefene intramuscular one time during the 17 day inpatient treatment period

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters of nalmefene

Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve

Secondary Outcome Measures

Safety and tolerability

Measure by adverse events, vital signs, ECG, clinical laboratory changes and nasal irritation following the administration of nalmefene

Full Information

NCT ID

NCT03129347

First Posted

April 19, 2017

Last Updated

March 23, 2018

Sponsor

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03129347

Brief Title

Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Official Title

Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

June 9, 2017 (Actual)

Study Completion Date

July 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Detailed Description

This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.

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

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nalmefene (high dose)

Arm Type

Experimental

Arm Description

Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period

Arm Title

Nalmefene and Intravail

Arm Type

Experimental

Arm Description

Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period

Arm Title

Nalmefene (low dose)

Arm Type

Experimental

Arm Description

Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period

Arm Title

Nalmefene Intramuscular

Arm Type

Experimental

Arm Description

Nalmefene intramuscular one time during the 17 day inpatient treatment period

Intervention Type

Drug

Intervention Name(s)

Nalmefene

Other Intervention Name(s)

Selincro

Intervention Description

Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters of nalmefene

Description

Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve

Time Frame

17 days

Secondary Outcome Measure Information:

Title

Safety and tolerability

Description

Measure by adverse events, vital signs, ECG, clinical laboratory changes and nasal irritation following the administration of nalmefene

Time Frame

17 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 Provide written informed consent Body Mass index (BMI) ranging from 18 to 32 kg/m2 Adequate venous access No clinically significant concurrent medical conditions Males subjects must agree to use an acceptable method of birth 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 subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited Agree not to ingest alcohol, drinks containing xanthine >500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study Exclusion Criteria: Please contact the site for more information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debra Kelsh, MD

Organizational Affiliation

Vince & Associates Clinical Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

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