Clinical trial NCT01761526: Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects
Official title: Parallel Group Trial to Evaluate the Pharmacokinetics and Safety / Tolerability of Single-Dose Treatment With Rotigotine Continuous Delivery System (10 cm2 / 4.5 mg) in Japanese and Caucasian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Rotigotine
Neupro
Japanese
Caucasian
Male
Female
Single dose
Pharmacokinetics
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Schwarz BioSciences GmbH
name: Alfred-Nobel-Str. 10
name: 40789 Monheim am Rhein
First posted: 2013-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, Electrocardiogram (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 (e.g. mechanical contraception (Intrauterine-Device IUD), sterilization, hysterectomy) 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

Primary outcomes:
measure: Area under the concentration-time curve (AUC) from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized [AUC (0-t)norm] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma [Cmax] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma [Cmax] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma [Cmax] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Secondary outcomes:
measure: Terminal half-life [t1/2] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Time of maximum concentration [tmax] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Amounts of unconjugated Rotigotine excreted in urine [Ae]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Renal Clearance [CLR] of unconjugated Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Terminal half-life [t1/2] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Time of maximum concentration [tmax] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Total body clearance of total Rotigotine normalized by body weight [CL/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Amount of total Rotigotine excreted into urine [Ae]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Fraction of total Rotigotine excreted into urine [fe (% of dose)]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Renal clearance [CLR] of total Rotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Terminal half-life [t1/2] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Time of maximum concentration [tmax] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Amount of total Despropylrotigotine excreted into urine [Ae]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Renal Clearance [CLR] of total Despropylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Terminal half-life [t1/2] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Time of maximum concentration [tmax] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Amount of total Desthienylethylrotigotine excreted into urine [Ae]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)]
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
measure: Renal clearance [CLR] of total Desthienylethylrotigotine
timeFrame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: 01
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: