- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05219669
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
December 8, 2022 updated by: Opiant Pharmaceuticals Inc
An Open-Label, Three-Period, Three-Treatment, Six-Sequence, Randomized Crossover Study of the Pharmacokinetics of Intranasal Nalmefene in Healthy Volunteers Using Three Dosing Regimens
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and as two doses in one nostrils; and to evaluate the safety and tolerability of nalmefene IN.
Study Overview
Detailed Description
Open-label, randomized, 3-period, 3-treatment, 6-sequence, ranodmised crossover study in 24 healthy volunteers. Subjects will be assigned to each of the 6 possible sequences. Each subject will receive 3 intranasal (IN) nalmefene doses:
- 3mg IN dose (one 0.1mL spray of a 30mg/mL solution in one nostril)
- 6mg IN dose (one 0.1mL spray of a 30mg/mL solution in each nostril)
- 6mg IN dose (two 0.1mL sprays of a 30mg/mL solution in one nostril) There will be a 6 day washout period between doses. Screening can occur up to 28 days before admission, subjects will then stay in the inpatient facility for 16 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Worldwide Clinical Trials
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged 18 to 55 years inclusive
- BMI ranging from 18 to 30 kg/m2, inclusive
- Adequate venous access
- Subjects must be non-smokers
Exclusion Criteria:
- History of clinically significant disease
- Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- Following an abnormal diet 4 weeks prior to screening
- Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
- Use of enzyme altering drugs 30 days before intervention
- Use of nasal products 28 days before intervention and throughout the study
- Previous or current opioid, alcohol, or other drug dependence
- Donated or received blood 30 days before intervention
- Women who are pregnant or breastfeeding at screening
- Women of childbearing potential unless surgically sterile or use effective contraception
- Male subjects of childbearing potential that do not agree to use effective contraception
- Male subjects who plan to donate sperm or have female partner(s) who are pregnant, lactating or planning to attempt to become pregnant
- Current or recent upper respiratory tract infection
- Allergic to nalmefene
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intranasal Nalmefene 1 spray in 1 nostril
Nalmefene Hydrochloride nasal spray, 3mg, 1 spray in 1 nostril
|
3mg nasal spray
|
Experimental: Intranasal Nalmefene 2 sprays in 1 nostril
Nalmefene Hydrochloride nasal spray, 6mg, 2 sprays in 1 nostril
|
3mg nasal spray
|
Experimental: Intranasal Nalmefene 1 spray in each nostril
Nalmefene Hydrochloride nasal spray, 6mg, 1 spray in each nostril
|
3mg nasal spray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: 48 hours
|
Maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
|
48 hours
|
Time to maximum plasma concentration (Tmax)
Time Frame: 48 hours
|
Time to maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
|
48 hours
|
Area under the curve (AUC)
Time Frame: 48 hours
|
Area under the curve of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
|
48 hours
|
Half-life (t1/2)
Time Frame: 48 hours
|
Half life of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ingela Danielsson, MD, Worldwide Clinical Trials
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 (Actual)
September 1, 2021
Primary Completion (Actual)
November 19, 2021
Study Completion (Actual)
November 22, 2021
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
January 21, 2022
First Posted (Actual)
February 2, 2022
Study Record Updates
Last Update Posted (Actual)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 8, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPNT003-PK-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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