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

NCT02617758 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR108059FENPAI1023
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy; Bioequivalence Study; JNJ-35685-AAA-G021; DURAGESIC

Outcome Measures

Primary Outcomes (5)

• Maximum Plasma Concentration (Cmax) of Fentanyl

  The Cmax is the maximum observed plasma concentration of Fentanyl.

  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

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

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

  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

• 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.

  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

• 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.

  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

• 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).

  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)

• Skin Adherence Score of Fentanyl Transdermal System

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

• Number of Participants with Adverse Events (AEs) and Serious AEs

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

Study Arms (2)

Treatment AB

EXPERIMENTAL

Participants 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.

Drug: Fentanyl

Treatment BA

EXPERIMENTAL

Participants 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.

Drug: Fentanyl

Interventions

Fentanyl DRUG

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

Also known as: DURAGESIC

Treatment AB; Treatment BA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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: November 17, 2015
• First Posted: December 1, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)