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Trial record 15 of 56 for:    insys

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

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ClinicalTrials.gov Identifier: NCT02576353
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Maximum concentration [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576353


Locations
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United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Neha N Parikh INSYS Therapeutics Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02576353     History of Changes
Other Study ID Numbers: INS002-15-049
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Fentanyl
Citric Acid
Sodium Citrate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action