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Trial record 12 of 56 for:    insys

Fentanyl Sublingual Spray in Opioid Naive Participants

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ClinicalTrials.gov Identifier: NCT02641340
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Pharmacology Drug: Fentanyl Sublingual Spray Drug: Fentanyl Citrate IV Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cycle 1, Cohort 1
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.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 1, Cohort 2
FSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 1, Cohort 3
FSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 1, Cohort 4
FSS low dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 2, Cohort 1
FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 2, Cohort 2
FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 2, Cohort 3
FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 2, Cohort 4
FSS medium dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 3, Cohort 1
FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every four hours for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 3, Cohort 2
FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every two hours for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 3, Cohort 3
FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every hour for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously

Experimental: Cycle 3, Cohort 4
FSS high dose (n=6) or Fentanyl Citrate IV 50 mcg (n=2) will be administered once every 30 minutes for a maximum of three doses.
Drug: Fentanyl Sublingual Spray
Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
Other Name: SUBSYS®

Drug: Fentanyl Citrate IV
Fentanyl Citrate 50 mcg, delivered intravenously




Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: within 24 hours (see detailed description) ]
  2. Time to reach peak or maximum concentration following drug administration (Tmax) [ Time Frame: within 24 hours (see detailed description) ]
  3. Area under the concentration-time curve [ Time Frame: within 24 hours (see detailed description) ]
    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)

  4. Apparent elimination rate constant in the terminal phase by non-compartmental analysis [ Time Frame: within 24 hours (see detailed description) ]
  5. Corresponding half-life (t1/2) [ Time Frame: within 24 hours (see detailed description) ]
  6. Trough concentration during multiple dosing prior to next dose (Ctrough) [ Time Frame: within 24 hours (see detailed description) ]
  7. Accumulation ratios [ Time Frame: within 24 hours (see detailed description) ]
    Categories: of Cmax (ARcmax), based on trough concentration (ARctrough), of AUCtau (ARauctau)

  8. Dose normalized Cmax [ Time Frame: within 24 hours (see detailed description) ]
  9. Dose normalized AUC [ Time Frame: within 24 hours (see detailed description) ]
    Categories: AUC0-1, AUC0-inf, AUCtau


Secondary Outcome Measures :
  1. Participants with respiratory depression requiring the use of naloxone [ Time Frame: within 24 hours ]
  2. Participants with hypoxia requiring oxygen administration [ Time Frame: within 24 hours ]
  3. Participants needing noninvasive respiratory maneuvers (e.g., jaw thrust, bag-valve mask) to improve respiratory status at any point during the study [ Time Frame: within 24 hours ]
  4. Participants with hypotension requiring intervention [ Time Frame: within 24 hours ]


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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): NCT02641340


Locations
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United States, California
Lotus Clinical Research, Inc.
Pasadena, California, United States, 91105
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Neha 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: NCT02641340     History of Changes
Other Study ID Numbers: INS002-15-050
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

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