Evaluation of Intranasal Naltrexone and Naloxone

NCT03851731 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Naltrexone-Ph1a-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Adverse Events

  15 days

• Vital Sign - Heart Rate

  12 days

• Vital Sign - Blood pressure (diastolic)

  12 days

• Vital Sign - Blood pressure (systolic)

  12 days

• Vital Sign - Respiration Rate

  12 days

Study Arms (3)

Naltrexone

EXPERIMENTAL

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

Drug: Naltrexone

Naloxone

EXPERIMENTAL

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

Drug: Naloxone

Naltrexol

EXPERIMENTAL

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

Drug: Naltrexol

Interventions

Naltrexone DRUG

Intranasal spray

Also known as: Vivitrol

Naltrexone

Naloxone DRUG

Intranasal spray

Also known as: Narcan

Naloxone

Naltrexol DRUG

Intranasal spray

Naltrexol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Contact site for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone; vivitrol; Naloxone; 6 beta-hydroxynaltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nora Chiang, PhD

  NIH / NIDA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 22, 2019
• Study Start: October 5, 2015
• Primary Completion: November 7, 2015
• Study Completion: November 7, 2015
• Last Updated: September 14, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share