NCT01780233

Brief Summary

The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 pain

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

January 28, 2013

Last Update Submit

January 28, 2013

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Time to reach the maximum drug concentration (Tmax) in plasma

    Up to 60 minutes pre-dose to 36 hours post-dose

Secondary Outcomes (8)

  • Maximum drug concentration (Cmax) in plasma

    Up to 60 minutes pre-dose to 36 hours post-dose

  • Area under the plasma concentration-time curve from time-0 to the time of the last quantifiable concentration (AUClast)

    Up to 60 minutes pre-dose to 36 hours post-dose

  • Area under the plasma concentration-time curve from time-0 extrapolated to infinity (AUCinf)

    Up to 60 minutes pre-dose to 36 hours post-dose

  • Percentage of AUCinf based on extrapolation (AUCextrap)

    Up to 60 minutes pre-dose to 36 hours post-dose

  • Observed elimination rate constant (λz)

    Up to 60 minutes pre-dose to 36 hours post-dose

  • +3 more secondary outcomes

Study Arms (3)

Fentanyl 400 µg sublingual spray + naltrexone 50 mg

EXPERIMENTAL

Patients received a single administration of 400 µg of fentanyl spray sublingually + naltrexone hydrochloride 50 mg orally.

Drug: Fentanyl 400 µg sublingual sprayDrug: Naltrexone 50 mg

Actiq® 400 µg transmucosally + naltrexone 50 mg

ACTIVE COMPARATOR

Patients received a single administration of 400 µg of Actiq® transmucosally + naltrexone hydrochloride 50 mg orally.

Drug: Actiq® 400 µg transmucosallyDrug: Naltrexone 50 mg

Fentanyl citrate injection 100 µg iv + naltrexone 50 mg

ACTIVE COMPARATOR

Patients received a single administration of 100 µg of fentanyl citrate intravenously + naltrexone hydrochloride 50 mg orally.

Drug: Fentanyl citrate injection 100 µg intravenouslyDrug: Naltrexone 50 mg

Interventions

Fentanyl 400 µg sublingual sprayDRUG
Fentanyl 400 µg sublingual spray + naltrexone 50 mg
Actiq® 400 µg transmucosallyDRUG

Actiq® 400 µg is a solid formulation of fentanyl citrate on a plastic stick that dissolves slowly in the mouth for absorption across the buccal mucosa.

Also known as: fentanyl citrate
Actiq® 400 µg transmucosally + naltrexone 50 mg
Fentanyl citrate injection 100 µg intravenouslyDRUG
Fentanyl citrate injection 100 µg iv + naltrexone 50 mg
Naltrexone 50 mgDRUG

Naltrexone hydrochloride was administered approximately 12 hours and 1 hour prior to and 12 hours after each dose of fentanyl to minimize the occurrence of unacceptable adverse effects (eg, decreased respiration, nausea) often associated with administration of fentanyl.

Actiq® 400 µg transmucosally + naltrexone 50 mgFentanyl 400 µg sublingual spray + naltrexone 50 mgFentanyl citrate injection 100 µg iv + naltrexone 50 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or non-pregnant, non-breast-feeding female between the ages of 18-55 inclusive.
  • Body Mass Index (BMI) between 18-30 kg/m\^2, inclusive, and body weight of at least 60 kg (132 lbs).
  • Subject was healthy according to the medical history, laboratory results, and physical examination.

You may not qualify if:

  • Had a presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Had a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
  • Had a significant history of hypersensitivity to opioid analgesics, fentanyl or any related products, naltrexone, or severe hypersensitivity reactions (like angioedema) to any drugs.
  • Had a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
  • Had donated blood or plasma within 30 days prior to the first dose of study medication or during the course of this study.
  • Had participated in another clinical trial within 30 days prior to the first dose of study medication or during the course of this study.
  • Had used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication or during the course of this study.
  • Had used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication or during the course of this study.
  • Had used enzyme altering drugs such as barbiturates, corticosteroids, phenothiazines, cimetidine, carbamazepine, etc, within 30 days prior to the first dose of study medication or during the course of this study.
  • Had used opioid analgesics within the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEDRA Clinical Research, LLC

Austin, Texas, 78759, United States

Location

Related Publications (1)

  • Parikh N, Goskonda V, Chavan A, Dillaha L. Single-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study. Clin Ther. 2013 Mar;35(3):236-43. doi: 10.1016/j.clinthera.2013.02.017.

    PMID: 23497761DERIVED

MeSH Terms

Conditions

Pain

Interventions

FentanylNaltrexone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Neha Parikh

    INSYS Therapeutics Inc

    STUDY DIRECTOR

  • Frederick A. Bieberdorf, MD

    CEDRA Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 31, 2013

Study Start

April 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)