Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rotigotine transdermal patch 1mg / 24 hours; Drug: Rotigotine transdermal patch 2 mg / 24 hours; Drug: Rotigotine transdermal patch 4 mg / 24 hours

• Registration Number: NCT01854216
• Lead Sponsor: UCB BIOSCIENCES GmbH

Brief Summary

To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian female and male healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Status Verified: 2013-05
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, ECG, hematology, clinical chemistry, urinalysis)
• Subject is of normal body-weight as determined by a body mass index ranging between 18 to 28 kg/m²
• Subject is Japanese or Caucasian. Japanese subjects are born in Japan and left Japan not more than 10 years ago. Both parents of the Japanese subjects are 100 % Japanese

Exclusion Criteria

• Subjects (females) without medically adequate contraception or on lactation or pregnant women. Subjects with oral contraception or hormone replacement within 4 weeks prior to eligibility assessment
• Subject has a history of chronic alcohol or drug abuse
• Subject has a consumption of more than 20 g of alcohol/day (amount corresponds to 0.5 l of beer/day or 0.25 l of wine/day or 3 glasses (à 2 cl) of liquor/day)
• Subject has a clinically relevant allergy
• Subject has a known or suspected drug hypersensitivity in particular, to any component of the trial medication
• Subject has any clinically significant abnormality in physical examination
• Subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100 bpm
• Subject has systolic blood pressure lower than 100 mmHg or higher than 145 mmHg or diastolic blood pressure higher than 95 mmHg or lower than 60 mmHg
• Subject has an atopic or eczematous dermatitis and/or an active skin disease or skin tumors
• Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotigotine in Japanese subjects	Rotigotine transdermal patch 2 mg / 24 hours	Repeated-Dose application of 1,2, and 4 mg / 24 hours Rotigotine in healthy Japanese subjects; Transdermal patch over 24 hours
Rotigotine in Japanese subjects	Rotigotine transdermal patch 4 mg / 24 hours	Repeated-Dose application of 1,2, and 4 mg / 24 hours Rotigotine in healthy Japanese subjects; Transdermal patch over 24 hours
Rotigotine in Caucasian subjects	Rotigotine transdermal patch 1mg / 24 hours	Multiple-Dose application of 1, 2, and 4 mg / 24 hours Rotigotine in healthy Caucasian subjects; Transdermal patch over 24 hours
Rotigotine in Caucasian subjects	Rotigotine transdermal patch 4 mg / 24 hours	Multiple-Dose application of 1, 2, and 4 mg / 24 hours Rotigotine in healthy Caucasian subjects; Transdermal patch over 24 hours
Rotigotine in Japanese subjects	Rotigotine transdermal patch 1mg / 24 hours	Repeated-Dose application of 1,2, and 4 mg / 24 hours Rotigotine in healthy Japanese subjects; Transdermal patch over 24 hours
Rotigotine in Caucasian subjects	Rotigotine transdermal patch 2 mg / 24 hours	Multiple-Dose application of 1, 2, and 4 mg / 24 hours Rotigotine in healthy Caucasian subjects; Transdermal patch over 24 hours

Primary Outcome Measures

Name	Time	Method
Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval (AUCtau,ss)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of total Rotigotine in plasma at steady-state (Cmax,ss)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of total Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)]	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Maximum concentration of unconjugated Rotigotine in plasma at steady-state (Cmax,ss)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

Secondary Outcome Measures

Name	Time	Method
Terminal half-life (t1/2) of unconjugated Rotigotine in steady-state	Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours
Time of maximum concentration (tmax) of unconjugated Rotigotine in steady-state (tmax,ss)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Apparent total body clearance of unconjugated Rotigotine normalized by Body Weight (CL/f/BW)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Apparent volume of distribution of unconjugated Rotigotine normalized by Body Weight (Vz/f/BW)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours
Terminal half-life (t1/2) of total Rotigotine in steady-state	Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours
Time of maximum concentration (tmax) of total Rotigotine in steady-state (tmax,ss)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Apparent total body clearance of total Rotigotine normalized by Body Weight (CL/f/BW)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Apparent volume of distribution of total Rotigotine normalized by Body Weight (Vz/f/BW)	Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours

Trial Locations

Locations (1)

1; 🇩🇪 Neuss, Germany