Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Not Applicable

Completed

• Conditions: Bioavailability
• Interventions: Drug: Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate Injection (FCI); Drug: Naltrexone

• Registration Number: NCT02138396
• Lead Sponsor: INSYS Therapeutics Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FCI first, then FSS	Fentanyl Citrate Injection (FCI)	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.
FCI first, then FSS	Fentanyl Sublingual Spray (FSS)	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.
FSS first, then FCI	Fentanyl Citrate Injection (FCI)	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.
FSS first, then FCI	Fentanyl Sublingual Spray (FSS)	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.
FSS first, then FCI	Naltrexone	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.
FCI first, then FSS	Naltrexone	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.

Primary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) by mode of administration	within 36 hours after dosing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Worldwide Clinical Trials Early Phase Services, LLC; 🇺🇸 San Antonio, Texas, United States