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

Phase 1

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Drug: Naltrexone; Other: Intravail

• Registration Number: NCT02750748
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Study Start: 2016-07
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

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Exclusion Criteria

• Please contact site for more information

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4mg Intranasal Naltrexone	Naltrexone	Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril
4mg Intranasal Naltrexone with Intravail	Intravail	Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
2mg Intramuscular Naltrexone	Naltrexone	Administer 2 mg formulation intramuscularly
50mg Naltrexone	Naltrexone	Administer 50mg formulation orally
4mg Intranasal Naltrexone with Intravail	Naltrexone	Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril

Primary Outcome Measures

Name	Time	Method
Plasma Concentration (AUC 0-inf)	48 hours	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 (Cmax)	48 hours	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)	48 hours	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)	48 hours	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

Name	Time	Method
Vital Signs	12 days	Measured before and after naltrexone administration
12-lead electrocardiogram	12 days	Measured before and after naltrexone administration
Nasal Irritation Scoring	5 days	Will be reported from the start of the first session to follow-up visit
Adverse Events	Maximum of 18 days	Will be reported from the start of the first session to follow-up visit

Trial Locations

Locations (1)

Vince and Associates Clinical Research, Inc.; 🇺🇸 Overland Park, Kansas, United States