Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

NCT02138396 | Completed

• 1 other identifier: INS-13-019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (1)

• Maximum concentration (Cmax) by mode of administration

  within 36 hours after dosing

Secondary Outcomes (2)

• Area under the concentration-time curve [AUC(last)] by mode of administration

  prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose

• Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration

  prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose

Study Arms (2)

FSS first, then FCI

EXPERIMENTAL

At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single dose of fentanyl sublingual spray (FSS) at the first visit. After a washout period of at least seven days, they receive a single intramuscular fentanyl citrate injection (FCI) at the second treatment visit.

Drug: Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate Injection (FCI); Drug: Naltrexone

FCI first, then FSS

EXPERIMENTAL

At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single intramuscular fentanyl citrate injection (FCI) at the first visit. After a washout period of at least seven days, they receive a single dose of fentanyl sublingual spray (FSS) at the second treatment visit.

Drug: Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate Injection (FCI); Drug: Naltrexone

Interventions

Fentanyl Sublingual Spray (FSS) DRUG

A single dose of fentanyl, 400 mcg per sublingual spray

Also known as: Subsys®

FCI first, then FSS; FSS first, then FCI

Fentanyl Citrate Injection (FCI) DRUG

A single dose of fentanyl citrate, 100 mcg per intramuscular injection

FCI first, then FSS; FSS first, then FCI

Naltrexone DRUG

Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.

FCI first, then FSS; FSS first, then FCI

Eligibility Criteria

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

You may qualify if:

• Meets protocol-specified criteria for qualification and contraception
• Good access to veins on both sides
• Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

You may not qualify if:

• Intolerance to venipuncture or injections
• Presence or history of oral disease, irritation or piercings
• Allergy or adverse response to fentanyl, naltrexone, or related drugs
• Tattoos, scarring, or other skin abnormality at planned injection sites
• History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Fentanyl; Naltrexone

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• George J Atiee, MD

  Worldwide Clinical Trials Early Phase Services, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (1)