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

• Sponsor: INSYS Therapeutics Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02576353
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 5
• Duration (Months): 1
• Patients Per Site Per Month: 49.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics and Pharmacodynamics	Drug: Fentanyl; Drug: Fentanyl Citrate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-label, Randomized, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 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).	Drug: Fentanyl; Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate; Fentanyl Citrate IV (FCIV)
Experimental: Cohort 2 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).	Drug: Fentanyl; Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate; Fentanyl Citrate IV (FCIV)
Experimental: Cohort 3 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).	Drug: Fentanyl; Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate; Fentanyl Citrate IV (FCIV)
Experimental: Cohort 4 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).	Drug: Fentanyl; Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate; Fentanyl Citrate IV (FCIV)
Experimental: Cohort 5 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).	Drug: Fentanyl; Fentanyl Sublingual Spray (FSS); Drug: Fentanyl Citrate; Fentanyl Citrate IV (FCIV)

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lotus Clinical Research	Pasadena	California	United States	91105

Sponsors and Collaborators

• INSYS Therapeutics Inc

Investigators

• Study Director: Neha N Parikh, INSYS Therapeutics Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: INSYS Therapeutics Inc
• ClinicalTrials.gov Identifier: NCT02576353
• Other Study ID Numbers: INS002-15-049
• First Posted: Oct 15, 2015
• Last Update Posted: Dec 2, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Fentanyl

Study Results

No Results Posted as of Dec 2, 2015