Evaluation of Intranasal Naltrexone and Naloxone

Opioid-use Disorder Clinical Trial

Official title:

Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851731
• Other study ID #: Naltrexone-Ph1a-001
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2015
• Est. completion date: November 7, 2015

Study information

• Verified date: February 2019
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 7, 2015
• Est. primary completion date: November 7, 2015
• 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.

• 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

Related Conditions & MeSH terms

• Opioid-use Disorder

Intervention

Drug:
• Naltrexone
Intranasal spray
• Naloxone
Intranasal spray
• Naltrexol
Intranasal spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter [maximum serum concentration - Cmax]	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
Primary	Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]	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
Primary	Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]	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	Adverse Events	To assess and document any adverse events measures	15 days
Secondary	Vital Sign - Heart Rate	To assess and document heart rate before and after intranasal dosing	12 days
Secondary	Vital Sign - Blood pressure (diastolic)	To assess and document blood pressure (diastolic) before and after intranasal dosing	12 days
Secondary	Vital Sign - Blood pressure (systolic)	To assess and document blood pressure (systolic) before and after intranasal dosing	12 days
Secondary	Vital Sign - Respiration Rate	To assess and document respiration rate before and after intranasal dosing	12 days
Secondary	Electrocardiogram	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