- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851731
Evaluation of Intranasal Naltrexone and Naloxone
September 11, 2020 updated by: National Institute on Drug Abuse (NIDA)
Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
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.
- Body mass index (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.
- Agree to use a reliable double-barrier method of birth control from the start of screening until one week 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:
- 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: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Naltrexone
Subject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
|
Intranasal spray
Other Names:
|
EXPERIMENTAL: Naloxone
Subject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
|
Intranasal spray
Other Names:
|
EXPERIMENTAL: Naltrexol
Subject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
|
Intranasal spray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameter [maximum serum concentration - Cmax]
Time Frame: 12 days
|
The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination.
|
12 days
|
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
Time Frame: 12 days
|
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve [AUCO-t] of naltrexone and naloxone when administered and in combination.
|
12 days
|
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
Time Frame: 12 days
|
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity [AUCO-inf] of naltrexone and naloxone when administered and in combination.
|
12 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 15 days
|
To assess and document any adverse events measures
|
15 days
|
Vital Sign - Heart Rate
Time Frame: 12 days
|
To assess and document heart rate before and after intranasal dosing
|
12 days
|
Vital Sign - Blood pressure (diastolic)
Time Frame: 12 days
|
To assess and document blood pressure (diastolic) before and after intranasal dosing
|
12 days
|
Vital Sign - Blood pressure (systolic)
Time Frame: 12 days
|
To assess and document blood pressure (systolic) before and after intranasal dosing
|
12 days
|
Vital Sign - Respiration Rate
Time Frame: 12 days
|
To assess and document respiration rate before and after intranasal dosing
|
12 days
|
Electrocardiogram
Time Frame: 12 days
|
Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval.
|
12 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Nora Chiang, PhD, NIH / 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 (ACTUAL)
October 5, 2015
Primary Completion (ACTUAL)
November 7, 2015
Study Completion (ACTUAL)
November 7, 2015
Study Registration Dates
First Submitted
February 19, 2019
First Submitted That Met QC Criteria
February 20, 2019
First Posted (ACTUAL)
February 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2020
Last Update Submitted That Met QC Criteria
September 11, 2020
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Naltrexone-Ph1a-001
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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