A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers

Healthy Clinical Trial

Official title:

An Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 4 New Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717157
• Other study ID #: CR100879
• Secondary ID: FENPAI10222012-0
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2012
• Last updated: March 5, 2014
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.

Description:

This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), 4-way crossover (participants will receive different interventions sequentially during the trial) study. The study will assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of 4 new formulations of fentanyl transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after a single application. All participants will be randomly assigned to 1 of 8 possible treatment sequences. During the 4 single-application treatment periods, each transdermal patch will be worn, on a different application site on the lateral side of the upper arm, continuously for 72 hours. The treatment periods will be separated by a washout period (period when receiving no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days to a maximum of 82 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg

• Participants must utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 3 months (men) or 1 week (women) after the study is completed

• Men must not donate sperm from the first drug administration until 3 months after completion of the study

• Each participant will receive a test for opioid dependency. Only those participants that pass this challenge test will be allowed to continue in this study

• Non-smoker

Exclusion Criteria:

• History of or current clinically significant medical illness, disease or condition that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results

• Clinically significant abnormal laboratorial values

• Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled

• History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Treatment A: DUROGESIC (8.4 mg fentanyl)
One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
• Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)
One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
• Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)
One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
• Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)
One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
• Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)
One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl serum concentrations		Up to 120 hours after applying the transdermal patch	No
Primary	Determination of residual fentanyl content in the worn patchs	The fentanyl content in the patchs following their removal at the end of 72 hours	At the end of 72 hours after applying the transdermal patch	No
Primary	The skin adherence score of the patches	The patch adherence will be scored from 0 to 4, where 0: >= 90% of the area adhered and no edges unattached; 1: >= 75% to < 90% adhered; 2: >= 50% and < 75% adhered; 3: > 0% and < 50% adhered, but not detached; 4: 0% adhered - patch detached.	Up to 72 hours after applying the transdermal patch	No
Secondary	The incidence of adverse events		Approximately 82 days	No