Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers
NCT ID: NCT02750748
Last Updated: 2017-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2016-07-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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4mg Intranasal Naltrexone
Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril
Naltrexone
4mg Intranasal Naltrexone with Intravail
Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
Naltrexone
Intravail
2mg Intramuscular Naltrexone
Administer 2 mg formulation intramuscularly
Naltrexone
50mg Naltrexone
Administer 50mg formulation orally
Naltrexone
Interventions
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Naltrexone
Intravail
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Principal Investigators
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Nora Chiang, PhD
Role: STUDY_CHAIR
National Institute on Drug Abuse (NIDA)
Locations
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Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Countries
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Other Identifiers
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Naltexone-Ph1a-002
Identifier Type: -
Identifier Source: org_study_id
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