Clinical trial NCT02576353: Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics and Pharmacodynamics
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum concentration
timeFrame: 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
measure: Time to maximum concentration
timeFrame: 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
measure: Area under the plasma concentration-time curve from 0 to the final time with a concentration at or above the limit of quantitation (LoQ)
timeFrame: 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
measure: Area under the plasma concentration-time curve from 0 to infinity
timeFrame: 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
measure: Apparent elimination rate constant in the terminal phase by noncompartmental analysis
timeFrame: 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
measure: Elimination half-life
timeFrame: 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
measure: Apparent oral clearance of drug following extravascular administration
timeFrame: 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
measure: Volume of distribution during terminal phase following extravascular administration
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
Study officials:
affiliation: INSYS Therapeutics Inc
name: Neha N Parikh
role: STUDY_DIRECTOR
References:
citation: Rauck R, Oh DA, Parikh N, Koch C, Singla N, Yu J, Nalamachu S, Vetticaden S. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a single ascending dose study in opioid-naive healthy volunteers. Curr Med Res Opin. 2017 Nov;33(11):1915-1920. doi: 10.1080/03007995.2017.1352496. Epub 2017 Aug 11.