Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jan 2016

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

December 23, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed

3 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed

Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

December 23, 2015

Last Update Submit

March 28, 2016

Conditions

Pharmacology

Outcome Measures

Primary Outcomes (9)

Maximum concentration (Cmax)
within 24 hours (see detailed description)
Time to reach peak or maximum concentration following drug administration (Tmax)
within 24 hours (see detailed description)
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)
Apparent elimination rate constant in the terminal phase by non-compartmental analysis
within 24 hours (see detailed description)
Corresponding half-life (t1/2)
within 24 hours (see detailed description)
Trough concentration during multiple dosing prior to next dose (Ctrough)
within 24 hours (see detailed description)
Accumulation ratios
Categories: of Cmax (ARcmax), based on trough concentration (ARctrough), of AUCtau (ARauctau)
within 24 hours (see detailed description)
Dose normalized Cmax
within 24 hours (see detailed description)
Dose normalized AUC
Categories: AUC0-1, AUC0-inf, AUCtau
within 24 hours (see detailed description)

Secondary Outcomes (4)

Participants with respiratory depression requiring the use of naloxone
within 24 hours
Participants with hypoxia requiring oxygen administration
within 24 hours
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
Participants with hypotension requiring intervention
within 24 hours

Study Arms (12)

Cycle 1, Cohort 1

EXPERIMENTAL

Fentanyl Sublingual Spray (FSS) low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses.