Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Rotigotine transdermal patch

• Registration Number: NCT01059903
• 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 two Rotigotine patches of two different formulations

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Primary Completion: 2010-02
• Study First Posted: 2010-02-01
• Study Completion: 2010-03
• Results First Submitted: 2011-02-04
• Results First Submitted QC: 2011-02-04
• Results First Posted: 2011-03-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Healthy White, male volunteers between 18 and 55 years of age (inclusive).
• BMI between 19 and 28 kg/m^2 (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rotigotine PR2.2.1 first	Rotigotine transdermal patch	Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
Rotigotine PR2.1.1 first	Rotigotine transdermal patch	Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Terminal Half-Life (t1/2) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	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-tz) Norm (Body Weight) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	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).
AUC(0- ∞) Norm (Apparent Dose)	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).
AUC(0- ∞) Norm (Body Weight)	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The AUC(0-inf) 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	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).
Cmax, Norm (Body Weight) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).
Tmax of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The tmax is the time to reach maximum plasma concentration after patch application.
Mean Residence Time (MRT) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The MRT is the mean residence time.
Rate Constant of Elimination (λz) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The λz of unconjugated rotigotine is the rate constant of elimination.
Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	The CL/f of unconjugated rotigotine is the apparent total body clearance.
Apparent Dose	24 hours	Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.