Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Bioavailability Clinical Trial

Official title:

Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138396
• Other study ID #: INS-13-019
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: December 11, 2014
• Start date: January 2014
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
• Fentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection
• Naltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) by mode of administration		within 36 hours after dosing	No
Secondary	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	No
Secondary	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	No