Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: rotigotine transdermal patch (Neupro®)

• Registration Number: NCT00957944
• Lead Sponsor: UCB Pharma

Brief Summary

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Results First Submitted: 2010-07-29
• Results First Submitted QC: 2010-08-26
• Results First Posted: 2010-09-22
• Status Verified: 2012-04
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• healthy, white, male volunteers between 18 and 55 years of age (inclusive)
• BMI between 19 and 28 kg/m² (inclusive)

Exclusion Criteria

• previous participation in a clinical study with Rotigotine
• history or current condition of epilepsy and/or seizures
• known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
• history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
• history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
• clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations
• positive HIV, hepatitis B or C test or positive alcohol or drug test
• relevant hepatic or renal dysfunction
• intake of medication that might interfere with the test drug within 2 weeks prior to dosing
• thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)	rotigotine transdermal patch (Neupro®)	Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days
Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	rotigotine transdermal patch (Neupro®)	Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days

Primary Outcome Measures

Name	Time	Method
Cmax of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The Cmax is the maximum plasma concentration.
AUC(0-tz) of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.
AUC(0-∞) of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity

Secondary Outcome Measures

Name	Time	Method
AUC(0-∞) Norm (Apparent Dose)	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).
AUC(0-∞) Norm (BW)	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).
Tmax of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The tmax is the time to reach a maximum plasma concentration after patch application.
AUC(0-tz) Norm (BW) of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).
Cmax,Norm (BW) of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).
MRT of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The MRT is the mean residence time.
λz of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The λz is the rate constant of elimination.
CL/f of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The CL/f is the apparent total body clearance.
Apparent Dose	48 hours	Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.
t1/2 of Unconjugated Rotigotine	Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.	The t1/2 is the terminal half- life.