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

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750748
• Other study ID #: Naltexone-Ph1a-002
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2016
• Last updated: January 11, 2017
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Exclusion Criteria:

• Please contact site for more information

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Naltrexone

Other:
• Intravail

Locations

Country	Name	City	State
United States	Vince and Associates Clinical Research, Inc.	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration (Cmax)	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	48 hours	No
Primary	Plasma Concentration (Tmax)	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	48 hours	No
Primary	Plasma Concentration (AUC 0-t)	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	48 hours	No
Primary	Plasma Concentration (AUC 0-inf)	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	48 hours	No
Secondary	Adverse Events	Will be reported from the start of the first session to follow-up visit	Maximum of 18 days	Yes
Secondary	Vital Signs	Measured before and after naltrexone administration	12 days	Yes
Secondary	12-lead electrocardiogram	Measured before and after naltrexone administration	12 days	Yes
Secondary	Nasal Irritation Scoring	Will be reported from the start of the first session to follow-up visit	5 days	Yes