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Pain, PostoperativePhase 1NCT01750060

Pharmacokinetic Characterization of the Active, Separated System With PK Controller (Fentanyl Iontophoretic Transdermal System, 40 Mcg Fentanyl Per Activation).

A Phase 1 study testing Fentanyl and Naltrexone in people with Pain, Postoperative, run by Incline 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

"This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence design. A total of 54 eligible subjects will receive three total treatments; one with intravenous (IV) infusion and two with the Study System. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Fentanyl and Naltrexone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Dec 2012to Mar 2013
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must provide written informed consent to participate in the study and document their understanding that they are free to withdraw from the study at any time.
  • Subjects must be healthy volunteers with no clinically relevant abnormalities, as determined by medical history, physical examination, blood chemistry, complete blood count, routine urinalysis (a microscopic urine analysis will be performed at the Investigator's discretion if the macroscopic analysis is abnormal), and electrocardiogram (ECG). Prior medical history, physical examination, and physical and laboratory findings will be reviewed and repeated as deemed appropriate by the supervising physician.
  • Subjects must be male or female volunteers, between ages 18 to 45 years, inclusive.
  • Subjects must have a Body Mass Index (BMI = weight [kg]/height2 [m2] of 18 to 28 kg/m2, inclusive.
  • Subjects must have an average blood pressure from three separate readings in the range of 100 to 139 mm Hg systolic (inclusive) and 50 and 89 mm Hg diastolic (inclusive) after sitting for 5 minutes before and between readings.
  • Subjects must have negative urine drug test results (for drugs of abuse) in each urine sample collected at the time of fentanyl dosing in each treatment period. Each urine sample will be tested for the presence of cannabinoids, amphetamines, barbiturates, benzodiazepines, cocaine, and opiates.
  • Subjects must have a negative alcohol test within the 24 hours before the start of fentanyl dosing in each treatment period.
  • Subjects must provide consent to use a medically acceptable method of contraception throughout the entire duration of the study and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or female partner include birth control pills, diaphragm with spermicide, intrauterine device (IUD), condom with spermicide, vaginal spermicidal suppository, surgical sterilization (6 months post-surgery), post-menopausal (not experienced a menstrual period for a minimum of 2 years), and progestin implant or injection (used consistently for the 3 months prior to study dosing).

Who cannot join

  • Subjects who are pregnant or plan to become pregnant during the time of their participation in this study
  • Subjects with clinically significant medical problems that, in the opinion of the supervising principal investigator, place the subject at undue risk of AEs. These conditions can include, but are not limited to, dermatologic, psychiatric, respiratory, cardiovascular, hepatic, renal, gastrointestinal, hematological, genitourinary, gynecologic, neurologic, or endocrine or other organ abnormality or pathology.
  • Subjects with evidence of orthostatic hypotension (e.g., supine-to-standing blood pressure decrease of ≥ 20 mm Hg systolic or ≥ 10 mm Hg diastolic AND ≥ 20 beats per minute (bpm) increase in heart rate after standing for 3 minutes) or with any reported symptoms of lightheadedness, dizziness, or fainting upon standing.
  • Subjects with resting heart rate < 50 or > 100 beats per minute.
  • Subjects with a history of chronic obstructive pulmonary disease (COPD) or any other lung disease (e.g., sleep apnea,asthma) that could cause CO2 retention beyond normal.
  • Subjects with oxygen saturation < 97% on room air.
Show all 30Show fewer
  • Subjects with active systemic skin disease or with active local skin disease, such as but not limited to, sunburn, psoriasis, or atopic dermatitis, which would preclude application of the Study System to the upper outer arm.
  • Subjects with a history of significant dermatologic cancers (e.g., melanoma or squamous cell carcinoma). Basal cell carcinomas that were superficial and do not involve the arms are acceptable.
  • Subjects with localized skin pigmentation (e.g., tattoos, sunburn, scars, branding, etc.) or open sores, body piercing, active skin lesions on the upper arms that could interfere with the ability to assess skin site reactions.
  • Subjects with excessive body hair at the intended application site and who refuse hair clipping at the application site
  • Subjects with a known allergy or hypersensitivity to fentanyl or other opioids, naltrexone, naloxone, cetylpyridinium chloride, skin adhesives, tapes, or other transdermal systems
  • Subjects who have reported using:
  • prescription medication (except for sex-hormone replacement or birth control) within 14 days prior to Day 0 of the first treatment period
  • over-the-counter (OTC) medication (except for multivitamin supplements or acetaminophen < 2 g/day) within 3 days prior to Day 0 of the first treatment period
  • alcohol, grapefruit juice, Seville oranges (e.g., marmalade), caffeine, or xanthine-containing products within 48 hours prior to dosing in each fentanyl treatment group
  • daily doses of herbal medication (e.g., Hypericum perforatum [St. John's Wort], Ephedra, Ginkgo, Ginseng, or garlic supplement) within 14 days before Day 0 of the first treatment period
  • prescription or OTC topical medications on the arms, including but not limited to corticosteroids and retinoids, within 28 days
  • Subjects planning to take prescription, OTC, or herbal medications from Day 0 of the first treatment period to the last study assessment with the exception of sex-hormone replacement, birth control, multivitamins, or acetaminophen (< 2 g/day). NOTE: use of topical medications, including antibiotics and corticosteroids, required to treat skin irritation resulting from application of the Study System is allowed.
  • Subjects who have received an investigational drug within the longer of: (a) the past 28 days, or (b) a period of five times the drug's half-life.
  • Subjects with a history or presence of drug or alcohol dependence or abuse.
  • Subjects who smoke > 10 cigarettes, 2 cigars, or 2 tobacco pipes per day within the last 6 months, as determined by medical history and/or subject's verbal report.
  • Subjects who are unable to abstain from smoking during the treatment periods.
  • Subjects who consume alcohol in quantities > 2 alcohol drinks every day, where 1 alcohol drink is defined as 12 ounces of beer, 1 ounce of hard liquor, or 4 ounces of wine.
  • Subjects who exhibit one or more signs or symptoms of opioid withdrawal due to the naloxone challenge test as determined by the Investigator(s).
  • Males with hemoglobin < 12.5 g/dL and females with hemoglobin < 11.5 g/dL.
  • Subjects who have donated blood, experienced a blood loss of > 400 mL within 28 days before dosing, or who plan to donate blood during the study.
  • Subjects who donated plasma within 7 days prior to dosing, or who plan to donate plasma during the study.
  • Subjects who are febrile (temperature > 100.3ºF) at check-in for each treatment period.
  • Subjects who are known to have tested positive for HIV or hepatitis B or hepatitis C.
  • Employees of the investigator or study center, as well as family members of the employees or the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PRACS Institute, Ltd.

    Fargo, North Dakota, 58104

Other trials in United States

About this study

"This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence design. A total of 54 eligible subjects will receive three total treatments; one with intravenous (IV) infusion and two with the Study System. Each subject will be randomly assigned to receive a treatment sequence consisting of Treatment A (IV fentanyl citrate), Study System Treatment B (170 mcAmp), and one of three additional Study System treatments (140 mcAmp or 200 mcAmp or 230 mcAmp) "

Read the detailed description

"The Study System is a single-use system that consists of two parts: a Drug Unit containing 10.8 mg fentanyl hydrochloride, and a Controller that supplies the dosing current. The two parts are packaged separately and assembled immediately prior to use. The Study System will be applied to the upper, outer arm of each subject. Fentanyl will be delivered from the Study System via transdermal iontophoresis using a current of 170 mcAmp (Treatment B), 140 mcAmp (Treatment C), 200 mcAmp (Treatment D), or 230 mcAmp (Treatment E). Each subject will be randomly assigned to a treatment sequence consisting of Treatment A (IV fentanyl citrate), Study System Treatment B (170 mcAmp), and one of three additional Study System treatments consisting of Treatment C (140 mcAmp), Treatment D (200 mcAmp), or Treatment E (230 mcAmp). Each subject will therefore receive a total of three treatments (A and B and either C, D, or E).

The specific treatments are outlined in detail below:

  • Treatment A: Fentanyl citrate (equivalent to 80 mcg fentanyl) administered over 20 minutes by IV infusion every hour through 23.33 hours.
  • Treatment B: Two consecutive 40 mcg fentanyl doses each delivered over 10 minutes by the Study System (170 mcAmp) every hour through 23.33 hours.
  • Treatment C: Two consecutive 35 mcg fentanyl doses, each delivered over 10 minutes by the Study System (140 mcAmp) every hour through 23.33 hours.
  • Treatment D: Two consecutive 50 mcg fentanyl doses, each delivered over 10 minutes by the Study System (200 mcAmp) every hour through 23.33 hours.
  • Treatment E: Two consecutive 54 mcg fentanyl doses, each delivered over 10 minutes by the Study System (230 mcAmp) every hour through 23.33 hours.

Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before the start of each fentanyl treatment and ending approximately 11 hours after completion of each treatment "

Being tested
Fentanyl, Naltrexone
Medical subject headings
Pain, Postoperative

What participants receive

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

Study groups in NCT01750060
Study groupRoleWhat they receive
Fentanyl citrate IV infusion & NaltrexoneActive comparatorFentanyl citrate (equivalent to 80 mcg fentanyl)administered over 20 minutes by IV infusion every hour through 23.33 hours. Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before the start of fentanyl treatment and ending approximately 11 hours after completion of treatment regimen to antagonize the clinical opioid effects of fentanyl.
Receives: Drug: Fentanyl; Drug: Naltrexone
Fentanyl Study System (170 mcAmps) & NaltrexoneExperimentalTwo consecutive 40 mcg fentanyl doses each delivered over 10 minutes by the Study System (170 mcAmps) every hour through 23.33 hours. Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before the start of fentanyl treatment and ending approximately 11 hours after completion of treatment regimen to antagonize the clinical opioid effects of fentanyl.
Receives: Drug: Fentanyl; Drug: Naltrexone
Fentanyl, Study System (140 mcAmp) & NaltrexoneExperimentalTwo consecutive 35 mcg fentanyl doses, each delivered over 10 minutes by the Study System (140 mcAmp) every hour through 23.33 hours. Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before the start of fentanyl treatment and ending approximately 11 hours after completion of treatment regimen to antagonize the clinical opioid effects of fentanyl.
Receives: Drug: Fentanyl; Drug: Naltrexone
Fentanyl, Study System (200 mcAmp) & NaltrexoneExperimentalTwo consecutive 50 mcg fentanyl doses, each delivered over 10 minutes by the Study System (200 mcAmp) every hour through 23.33 hours. Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before the start of fentanyl treatment and ending approximately 11 hours after completion of treatment regimen to antagonize the clinical opioid effects of fentanyl.
Receives: Drug: Fentanyl; Drug: Naltrexone
Fentanyl, Study System (230 mcAmp) & NaltrexoneExperimentalTwo consecutive 54 mcg fentanyl doses, each delivered over 10 minutes by the Study System (230 mcAmp) every hour through 23.33 hours. Naltrexone (50 mg) will be administered orally (PO) every 12 hours, beginning 14 hours before the start of fentanyl treatment and ending approximately 11 hours after completion of treatment regimen to antagonize the clinical opioid effects of fentanyl.
Receives: Drug: Fentanyl; Drug: Naltrexone

What is being measured

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

  1. Measure area under the fentanyl concentration-time curve (AUC)

    Measure area under the fentanyl concentration-time curve (AUC), one of the five key pharmacokinetic (PK) parameters for the Active, Separated System with PK Controller in the study population.

    Measured: The two-hour period for hours 23-24 for all treatment groups.

  2. Measure maximum fentanyl concentration (Cmax)

    Measure maximum fentanyl concentration (Cmax), one of the five key pharmacokinetic (PK) parameters for the Active, Separated System with PK Controller in the study population.

    Measured: The two-hour period for hours 23-24 for all treatment groups.

  3. Measure time to Cmax (tmax)

    Measure time to Cmax (tmax), one of the five key pharmacokinetic (PK) parameters for the Active, Separated System with PK Controller in the study population.

    Measured: The two-hour period for hours 23-24 for all treatment groups.

  4. Measure terminal half-life (t½)

    Measure terminal half-life (t½), one of the five key pharmacokinetic (PK) parameters for the Active, Separated System with PK Controller in the study population.

    Measured: The two-hour period for hours 23-24 for all treatment groups.

  5. Measure the amount of fentanyl absorbed

    Measure the amount of fentanyl absorbed, one of the five key pharmacokinetic (PK) parameters for the Active, Separated System with PK Controller in the study population.

    Measured: The two-hour period for hours 23-24 for all treatment groups.

Timeline

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

  1. First posted17 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01750060
Sponsor's protocol ID
PK2011-001
Status last verified
Apr 2013
First submitted
10 Dec 2012
Last updated
19 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fentanyl and Naltrexone in people with Pain, Postoperative, run by Incline Therapeutics, Inc. at 1 site in United States.

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 8 inclusion and 30 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 19 Apr 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?

Measure area under the fentanyl concentration-time curve (AUC) (time frame: The two-hour period for hours 23-24 for all treatment groups.). The study lists 5 primary outcomes in all. 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 NCT01750060.

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 19 Apr 2013.

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