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Completed

NCT Number: NCT02576353

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

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.

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Key information

Conditions

Pharmacokinetics and Pharmacodynamics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lotus Clinical Research

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Treatment and study plan

Fentanyl

Drug

Fentanyl Sublingual Spray (FSS)

Fentanyl Citrate

Drug

Fentanyl Citrate IV (FCIV)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

INSYS Therapeutics Inc

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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