PainPhase 1NCT01780233

Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

A Phase 1 study testing Fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally and Fentanyl citrate injection 100 µg intravenously in people with Pain, run by INSYS Therapeutics Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally and Fentanyl citrate injection 100 µg intravenously
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Apr 2007to May 2007
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

CEDRA Clinical Research, LLC
Austin, Texas, 78759

Other trials in United States

About this study

Official title: A Single-dose Crossover Study of Fentanyl Sublingual Spray 400 Mcg Versus Actiq® 400 Mcg Versus Fentanyl Citrate Injection (iv) 100 Mcg Under Fasted Conditions

Read the detailed description

This was a Phase I, single-dose, open-label, randomized, 3-period, 3-treatment cross over study in which 21 healthy subjects received single doses of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously following a 10-hour overnight fast. There was a 7 day washout period between treatments.

Conditions: Pain
Being tested: Fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, Fentanyl citrate injection 100 µg intravenously, Naltrexone 50 mg
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fentanyl 400 µg sublingual sprayDrug
Actiq® 400 µg transmucosallyDrug
Also called fentanyl citrate
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.
Fentanyl citrate injection 100 µg intravenouslyDrug
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.

Study groups in NCT01780233
Study group	Role	What they receive
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. Receives: Drug: Fentanyl 400 µg sublingual spray; Drug: 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. Receives: Drug: Actiq® 400 µg transmucosally; Drug: 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. Receives: Drug: Fentanyl citrate injection 100 µg intravenously; Drug: Naltrexone 50 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to reach the maximum drug concentration (Tmax) in plasma
Measured: Up to 60 minutes pre-dose to 36 hours post-dose

Secondary outcomes (8)

Maximum drug concentration (Cmax) in plasma
Measured: 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)
Measured: 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)
Measured: Up to 60 minutes pre-dose to 36 hours post-dose
Percentage of AUCinf based on extrapolation (AUCextrap)
Measured: Up to 60 minutes pre-dose to 36 hours post-dose
Observed elimination rate constant (λz)
Measured: Up to 60 minutes pre-dose to 36 hours post-dose
Observed terminal elimination half-life (T1/2)
Measured: Up to 60 minutes pre-dose to 36 hours post-dose
Time of the last measurable concentration of drug (Tlast) in plasma
Measured: Up to 60 minutes pre-dose to 36 hours post-dose
Last quantifiable drug concentration (Clast) in plasma
Measured: Up to 60 minutes pre-dose to 36 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007May 2007

First posted31 Jan 2013 (estimated)
Study startApr 2007
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01780233
Sponsor's protocol ID: INS-06-003
Status last verified: Jan 2013
First submitted: 28 Jan 2013
Last updated: 31 Jan 2013
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 23497761

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose Crossover Study of Fentanyl Sublingual Spray 400 Mcg Versus Actiq® 400 Mcg Versus Fentanyl Citrate Injection (iv) 100 Mcg Under Fasted Conditions
ClinicalTrials.gov ID: NCT01780233
Acronym / sponsor ID: INS-06-003
Conditions: Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: INSYS Therapeutics IncIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 31 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Fentanyl 400 µg sublingual spray + naltrexone 50 mg	Experimental	Drug: Fentanyl 400 µg sublingual spray, Drug: Naltrexone 50 mgPatients received a single administration of 400 µg of fentanyl spray sublingually + naltrexone hydrochloride 50 mg orally.
Actiq® 400 µg transmucosally + naltrexone 50 mg	Active comparator	Drug: Actiq® 400 µg transmucosally, Drug: Naltrexone 50 mgPatients received a single administration of 400 µg of Actiq® transmucosally + naltrexone hydrochloride 50 mg orally.
Fentanyl citrate injection 100 µg iv + naltrexone 50 mg	Active comparator	Drug: Fentanyl citrate injection 100 µg intravenously, Drug: Naltrexone 50 mgPatients received a single administration of 100 µg of fentanyl citrate intravenously + naltrexone hydrochloride 50 mg orally.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fentanyl 400 µg sublingual spray	Drug	Fentanyl 400 µg sublingual spray + naltrexone 50 mg
Actiq® 400 µg transmucosallyAlso: fentanyl citrateActiq® 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.	Drug	Actiq® 400 µg transmucosally + naltrexone 50 mg
Fentanyl citrate injection 100 µg intravenously	Drug	Fentanyl citrate injection 100 µg iv + naltrexone 50 mg
Naltrexone 50 mgNaltrexone 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.	Drug	Actiq® 400 µg transmucosally + naltrexone 50 mg, Fentanyl 400 µg sublingual spray + naltrexone 50 mg, Fentanyl citrate injection 100 µg iv + naltrexone 50 mg

Primary outcome

Time to reach the maximum drug concentration (Tmax) in plasma
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose

8 secondary outcomes

Maximum drug concentration (Cmax) in plasma
Time frame: 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)
Time frame: 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)
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose
Percentage of AUCinf based on extrapolation (AUCextrap)
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose
Observed elimination rate constant (λz)
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose
Observed terminal elimination half-life (T1/2)
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose
Time of the last measurable concentration of drug (Tlast) in plasma
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose
Last quantifiable drug concentration (Clast) in plasma
Time frame: Up to 60 minutes pre-dose to 36 hours post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Derived from this study: PubMed 23497761Parikh 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neha Parikh study director

INSYS Therapeutics Inc

Frederick A. Bieberdorf, MD principal investigator

CEDRA Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to reach the maximum drug concentration (Tmax) in plasma (time frame: Up to 60 minutes pre-dose to 36 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01780233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.