Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

Phase 1

Completed

• Conditions: Pharmacokinetics and Pharmacodynamics
• Interventions: Drug: Fentanyl; Drug: Fentanyl Citrate

• Registration Number: NCT02576353
• Lead Sponsor: INSYS Therapeutics Inc

Brief Summary

The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Meets protocol-specified criteria for qualification and contraception
• 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

• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Fentanyl Citrate	After a 10-hour fast, the 10 participants in this cohort are randomized to receive Fentanyl Sublingual (under the tongue) Spray (FSS) 100 mcg (n=8), or Fentanyl Citrate Intravenously (FCIV) 50 mcg (n=2).
Cohort 4	Fentanyl Citrate	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 600 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 3	Fentanyl Citrate	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 400 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 2	Fentanyl Citrate	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 200 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 5	Fentanyl Citrate	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 800 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 1	Fentanyl	After a 10-hour fast, the 10 participants in this cohort are randomized to receive Fentanyl Sublingual (under the tongue) Spray (FSS) 100 mcg (n=8), or Fentanyl Citrate Intravenously (FCIV) 50 mcg (n=2).
Cohort 2	Fentanyl	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 200 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 3	Fentanyl	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 400 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 4	Fentanyl	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 600 mcg (n=8), or FCIV 50 mcg (n=2).
Cohort 5	Fentanyl	After a 10-hour fast, the 10 participants in this cohort are randomized to receive FSS 800 mcg (n=8), or FCIV 50 mcg (n=2).

Primary Outcome Measures

Name	Time	Method
Maximum concentration	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Time to maximum concentration	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Area under the plasma concentration-time curve from 0 to the final time with a concentration at or above the limit of quantitation (LoQ)	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Area under the plasma concentration-time curve from 0 to infinity	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Apparent elimination rate constant in the terminal phase by noncompartmental analysis	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Elimination half-life	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Apparent oral clearance of drug following extravascular administration	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing
Volume of distribution during terminal phase following extravascular administration	0 (pre-dose), 5, 10, 20, 30 and 40 minutes after dosing and at 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, and 24 hours after dosing

Trial Locations

Locations (1)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States