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

INSYS Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics and Pharmacodynamics

Treatments: Drug: Fentanyl; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576353

INS002-15-049

Details and patient eligibility

About

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.

Enrollment: 50 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)

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50 participants in 5 patient groups

Cohort 1

Experimental group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl Citrate

Cohort 2

Experimental group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl Citrate

Cohort 3

Experimental group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl Citrate

Cohort 4

Experimental group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl Citrate

Cohort 5

Experimental group

Description:

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).

Treatment:

Drug: Fentanyl

Drug: Fentanyl Citrate