Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02641340 · ClinicalTrials.gov registry record · Phase 1

Fentanyl Sublingual Spray in Opioid Naive Participants

A Phase 1 study, sponsored by INSYS Therapeutics.

Completed
Registry status
Phase 1
Development phase
96
Enrollment target

NCT02641340: Completed Phase 1 study, sponsored by INSYS Therapeutics.

NCT02641340 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02641340, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
96 participants
Enrollment target

Study 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.

Interventions

  • DRUG Fentanyl Sublingual Spray
  • DRUG Fentanyl Citrate IV

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2016-01
Est. Completion 2016-03
Phase Phase 1
INSYS Therapeutics

35 total trials

What the finished NCT02641340 record still lists

NCT02641340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).

The record links to 0 conditions, and to 2 interventions - of which Fentanyl Sublingual Spray is the first listed.

NCT02641340 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02641340 about?

NCT02641340 is a clinical study titled "Fentanyl Sublingual Spray in Opioid Naive Participants". 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 f...

What is the current status of trial NCT02641340?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2016-01. Estimated completion is 2016-03.

What interventions are being tested in trial NCT02641340?

The interventions under investigation include: Fentanyl Sublingual Spray (DRUG), Fentanyl Citrate IV (DRUG).

Who is sponsoring clinical trial NCT02641340?

This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02641340's enrollment target sits among peer trials

96 600th of 2000 higher than 1,391 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03401762 · 96 participants · NA

    Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke

  • NCT03471260 · 96 participants · Phase 1

    Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

  • NCT03549559 · 96 participants · NA

    Imaging Histone Deacetylase in the Heart

  • NCT03841058 · 96 participants · Phase 2

    Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT02641340, the US trial registry maintained by the National Library of Medicine. NCT02641340 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.