Fentanyl Sublingual Spray in Opioid Naive Participants

INSYS Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pharmacology

Treatments: Drug: Fentanyl Citrate IV; Drug: Fentanyl Sublingual Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02641340

INS002-15-050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 12 patient groups

Cycle 1, Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 1, Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 1, Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 1, Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 2, Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 2, Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 2, Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 2, Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 3, Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 3, Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 3, Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV

Cycle 3, Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl Sublingual Spray

Drug: Fentanyl Citrate IV