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

UCB BIOSCIENCES GmbH26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Rotigotine transdermal patch 1mg / 24 hoursDRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours

Rotigotine transdermal patch 2 mg / 24 hoursDRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours

Rotigotine transdermal patch 4 mg / 24 hoursDRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Neuss, Germany

Outcomes

Primary Outcomes

Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss)

Time frame: 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)]

Time frame: 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)

Time frame: 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)]

Time frame: 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)]

Time frame: 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)]

Time frame: 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)

Time frame: 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)]

Data from ClinicalTrials.gov

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Secondary Outcomes

Terminal half-life (t1/2) of unconjugated Rotigotine in steady-state

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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