Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects
NCT ID: NCT02576353
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2015-10-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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).
Fentanyl
Fentanyl Sublingual Spray (FSS)
Fentanyl Citrate
Fentanyl Citrate IV (FCIV)
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).
Fentanyl
Fentanyl Sublingual Spray (FSS)
Fentanyl Citrate
Fentanyl Citrate IV (FCIV)
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).
Fentanyl
Fentanyl Sublingual Spray (FSS)
Fentanyl Citrate
Fentanyl Citrate IV (FCIV)
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).
Fentanyl
Fentanyl Sublingual Spray (FSS)
Fentanyl Citrate
Fentanyl Citrate IV (FCIV)
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).
Fentanyl
Fentanyl Sublingual Spray (FSS)
Fentanyl Citrate
Fentanyl Citrate IV (FCIV)
Interventions
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Fentanyl
Fentanyl Sublingual Spray (FSS)
Fentanyl Citrate
Fentanyl Citrate IV (FCIV)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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INSYS Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Neha N Parikh
Role: STUDY_DIRECTOR
INSYS Therapeutics Inc
Locations
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Lotus Clinical Research
Pasadena, California, United States
Countries
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References
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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.
Other Identifiers
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INS002-15-049
Identifier Type: -
Identifier Source: org_study_id