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HealthyPhase 1NCT02617758

Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants

A Phase 1 study testing Fentanyl in people with Healthy, run by Janssen Research & Development, LLC 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 purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Nov 2015to Jun 2016
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Not of childbearing potential: postmenopausal [greater than (>) 45 years of age with amenorrhea for at least 12 months; permanently sterilized (example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • Of childbearing potential and practicing a reliable method of birth control, throughout the study and for 1 week after the study is completed. The method must be consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); double-barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)
  • A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at Screening and urine pregnancy test at Day -1 of the first treatment period
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study
  • Participant must be willing and able to adhere to the prohibitions and restrictions as specified in the protocol

Who cannot join

  • Participant has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency [(creatinine clearance below 60 milliliter per minute (mL/min)]; thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs or 12 lead ECG at Screening as deemed appropriate by the investigator
  • Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product [example, antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy]. Throughout the study, prescription or nonprescription medication (including vitamins and herbal supplements) other than the study drugs [Fentanyl Transdermal Therapeutic System (TTS), Naloxone and Naltrexone] are prohibited, except for acetaminophen and hormonal contraceptives by women participants. The use of acetaminophen is allowed until 3 days before each study drug administration. Throughout the study, a maximum of 3 doses per day of 325 milligram (mg) acetaminophen, and no more than 3 gram (g) during the time of confinement of each dosing period will be allowed for the treatment of headache or other pain
  • History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens (phencyclidine, psilocybin, and d-lysergic acid diethylamide [LSD]), or barbiturates at Screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Cypress, California

Other trials in United States

About this study

Official title: An Open-Label, Randomized, Single Application, Two-Period Crossover, Pivotal Bioequivalence Study to Evaluate the Bioequivalence of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Subjects

The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.

Read the detailed description

This is a single-center, randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single application and 2-way Crossover (the same medications provided to all participants but in different sequence) pivotal study to determine the bioequivalence of marketed reference formulation DURAGESIC and the test formulation Fentanyl transdermal system (JNJ-35685-AAA-G021). Approximately 56 healthy participants will participate in this study. Participants will be randomly assigned to 1 of 2 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21 days before the first study drug administration of the first period), an open-label treatment Phase consisting of 2 single-application treatment periods (26 days) and End-of-Study (at the end of Period 2). The total study duration for each participant will be from 43 days to a maximum of 59 days. Participants will receive a single application 100 microgram per hour (mcg/h) dose of DURAGESIC fentanyl transdermal system as Treatment A (Reference) and 100 mcg/h Fentanyl transdermal system (JNJ-35685-AAA-G021) as Treatment B (Test). Bioequivalence will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Conditions
Healthy
Being tested
Fentanyl
Keywords
Healthy, Bioequivalence Study, JNJ-35685-AAA-G021, DURAGESIC

What participants receive

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

  • FentanylDrug

    Also called DURAGESIC

    Participants will receive single application of DURAGESIC fentanyl transdermal system 100 µg/h dose in one of the treatment periods.

  • FentanylDrug

    Also called JNJ-35685-AAA-G021

    Participants will receive single application of Fentanyl transdermal system (JNJ-35685-AAA-G021) 100 microgram per hour (µg/h) dose in one of the treatment periods.

Study groups in NCT02617758
Study groupRoleWhat they receive
Treatment ABExperimentalParticipants will receive Treatment A (single application of DURAGESIC fentanyl transdermal system 100 microgram per hour (µg/h) dose) as Reference in Period 1; followed by Treatment B (single application of Fentanyl transdermal system [JNJ-35685-AAA-G021] 100 µg/h dose) as test in Period 2. A washout period of at least 8 days and no more than 14 days will be maintained between each treatment period.
Receives: Drug: Fentanyl
Treatment BAExperimentalParticipants will receive Treatment B [single application of Fentanyl transdermal system (JNJ-35685-AAA-G021) 100 microgram per hour (µg/h) dose] as test in Period 1; followed by Treatment A (single application of DURAGESIC fentanyl transdermal system 100 µg/h dose) as Reference in Period 2. A washout period of at least 8 days and no more than 14 days will be maintained between each treatment period.
Receives: Drug: Fentanyl

What is being measured

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

  1. Maximum Plasma Concentration (Cmax) of Fentanyl

    The Cmax is the maximum observed plasma concentration of Fentanyl.

    Measured: Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period

  2. Time to Reach the Maximum Plasma Concentration (Tmax) of Fentanyl

    The Tmax is the time to reach the maximum observed plasma concentration of Fentanyl.

    Measured: Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period

  3. Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of Fentanyl

    The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.

    Measured: Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period

  4. Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Fentanyl

    The AUC (0-infinity) is the area under the plasma Fentanyl concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma Fentanyl concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.

    Measured: Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period

  5. Terminal Half-life (t[1/2]) of Fentanyl

    Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).

    Measured: Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period

Secondary outcomes (2)

  1. Skin Adherence Score of Fentanyl Transdermal System

    The Food and Drug Administration (FDA) scoring system will be the basis to evaluate adhesion performance of the transdermal system. The scoring system has scale from 0-4. Where, 0 = system adhered to greater than or equal to (>=) 90 percent (%) adhered of the area, essentially no lift off the skin; 1 = system >=75% to less than (<) 90% adhered, some edges only lifting off the skin; 2 = system >=50% to <75% adhered, less than half of the patch lifting off the skin; 3 = system greater than (>) 0% to <50% adhered, more than half of the patch lifting off the skin but not falling off; 4 = system 0% adhered to skin, patch completely off the skin.

    Measured: Up to 72 hours post-dose on Day 1 of each period

  2. Number of Participants with Adverse Events (AEs) and Serious AEs

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Screening up to End-of-Study (Approximately Day 59)

Timeline

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

  1. First posted1 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02617758
Sponsor's protocol ID
CR108059
Other IDs
FENPAI1023
Status last verified
Jan 2025
First submitted
17 Nov 2015
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fentanyl in people with Healthy, run by Janssen Research & Development, LLC 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 6 inclusion and 5 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 3 Feb 2025. 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?

Maximum Plasma Concentration (Cmax) of Fentanyl (time frame: Pre-dose; 0.5, 1, 2, 3, 5, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 73, 74, 78, 84, 94, 108 and 120 hours post-dose on Day 1 of each period). 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 NCT02617758.

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 3 Feb 2025.

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