Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

INSYS Therapeutics

Status: Completed

Conditions: Bioavailability

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02138396

INS-13-019

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

FSS first, then FCI

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray (FSS)

Drug: Fentanyl Citrate Injection (FCI)

Drug: Naltrexone

FCI first, then FSS

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray (FSS)

Drug: Fentanyl Citrate Injection (FCI)

Drug: Naltrexone