NCT02641340

Fentanyl Sublingual Spray in Opioid Naive Participants

A Phase 1, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fentanyl Sublingual Spray in Opioid Naive Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants. The secondary objective is to determine the safety and tolerability of multiple dose administration of fentanyl sublingual spray in opioid naive subjects.

Detailed description

For all cycles, blood will be drawn according to the following schedule: The 0 time (pre-dose) blood sample will be collected within 60 minutes prior to first study drug administration. Cohort l: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2, 4 (prior to second-dose), 4.083, 4.25, 4.5, 5, 6, 8 (prior to third-dose), 8.083, 8.25, 8.5, 9, 10, 12, 16 and 24 hours after the first dose. Cohort 2: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2 (prior to second-dose), 2.083, 2.25, 2.5, 3, 4 (prior to third-dose), 4.083, 4.25, 4.5, 5, 6, 8, 10, 12, 16 and 24 hours after the first dose. Cohort 3: 0 (pre-dose), 5, 15, 30 and 45 minutes after the first dose and at 1 (prior to second-dose), 1.083, 1.25, l.5, 1.75, 2 (prior to third-dose), 2.083, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose. Cohort 4: 0 (pre-dose), 5, 15, 30 (prior to the second-dose), 35, and 45 minutes after the first dose and at I (prior to the third-dose), 1.083, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.

Conditions

• Pharmacology

Interventions

Type	Name	Description
DRUG	Fentanyl Sublingual Spray	Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
DRUG	Fentanyl Citrate IV	Fentanyl Citrate 50 mcg, delivered intravenously

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-12-29
• Last updated: 2016-03-30

Locations

1 site across 1 country: United States