Fentanyl Sublingual Spray in Opioid Naive Participants

Pharmacology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641340
• Other study ID #: INS002-15-050
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2015
• Last updated: March 28, 2016
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• 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

• 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

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

Related Conditions & MeSH terms

• Pharmacology

Intervention

Drug:
• Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
• Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Locations

Country	Name	City	State
United States	Lotus Clinical Research, Inc.	Pasadena	California

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)		within 24 hours (see detailed description)	No
Primary	Time to reach peak or maximum concentration following drug administration (Tmax)		within 24 hours (see detailed description)	No
Primary	Area under the concentration-time curve	Categories: during a dosing interval (AUCtau ), from the time of dosing to infinity (AUC0-inf), from the time of dosing to the last quantifiable time point (AUC0-t)	within 24 hours (see detailed description)	No
Primary	Apparent elimination rate constant in the terminal phase by non-compartmental analysis		within 24 hours (see detailed description)	No
Primary	Corresponding half-life (t1/2)		within 24 hours (see detailed description)	No
Primary	Trough concentration during multiple dosing prior to next dose (Ctrough)		within 24 hours (see detailed description)	No
Primary	Accumulation ratios	Categories: of Cmax (ARcmax), based on trough concentration (ARctrough), of AUCtau (ARauctau)	within 24 hours (see detailed description)	No
Primary	Dose normalized Cmax		within 24 hours (see detailed description)	No
Primary	Dose normalized AUC	Categories: AUC0-1, AUC0-inf, AUCtau	within 24 hours (see detailed description)	No
Secondary	Participants with respiratory depression requiring the use of naloxone		within 24 hours	No
Secondary	Participants with hypoxia requiring oxygen administration		within 24 hours	No
Secondary	Participants needing noninvasive respiratory maneuvers (e.g., jaw thrust, bag-valve mask) to improve respiratory status at any point during the study		within 24 hours	No
Secondary	Participants with hypotension requiring intervention		within 24 hours	No