HealthyPhase 1NCT01761526
Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects
A Phase 1 study testing Rotigotine transdermal patch in people with Healthy, run by UCB BIOSCIENCES GmbH at 1 site in Germany.
Trial summary
To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rotigotine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2002to Dec 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.
- Conditions
- Healthy
- Being tested
- Rotigotine transdermal patch
- Keywords
- Rotigotine, Neupro, Japanese, Caucasian, Male, Female, Single dose, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine transdermal patchDrug
Also called Neupro
Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine in Healthy Japanese | Experimental | * Rotigotine transdermal patch
* Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects
* Transdermal patch over 24 hours Receives: Drug: Rotigotine transdermal patch |
| Rotigotine in Caucasian | Experimental | * Rotigotine transdermal patch
* Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects
* Transdermal patch over 24 hours Receives: Drug: Rotigotine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
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
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Secondary outcomes (32)
Terminal half-life [t1/2] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amounts of unconjugated Rotigotine excreted in urine [Ae]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal Clearance [CLR] of unconjugated Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance of total Rotigotine normalized by body weight [CL/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amount of total Rotigotine excreted into urine [Ae]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of total Rotigotine excreted into urine [fe (% of dose)]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal clearance [CLR] of total Rotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amount of total Despropylrotigotine excreted into urine [Ae]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal Clearance [CLR] of total Despropylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amount of total Desthienylethylrotigotine excreted into urine [Ae]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)]
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal clearance [CLR] of total Desthienylethylrotigotine
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Measured: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startOct 2002
- Primary completionOct 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schwarz BioSciences GmbH, Alfred-Nobel-Str. 10, 40789 Monheim am Rhein
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761526
- Sponsor's protocol ID
- SP0717
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01761526
- Acronym / sponsor ID
- SP0717
- Conditions
- Healthy
- Keywords
- Rotigotine, Neupro, Japanese, Caucasian, Male, Female, Single dose, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Schwarz BioSciences GmbH, Alfred-Nobel-Str. 10, 40789 Monheim am Rhein
- Study start
- Oct 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotigotine in Healthy Japanese | Experimental | Drug: Rotigotine transdermal patch* Rotigotine transdermal patch * Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects * Transdermal patch over 24 hours |
| Rotigotine in Caucasian | Experimental | Drug: Rotigotine transdermal patch* Rotigotine transdermal patch * Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects * Transdermal patch over 24 hours |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotigotine transdermal patchAlso: NeuproRotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2) | Drug | Rotigotine in Caucasian, Rotigotine in Healthy Japanese |
Primary outcome
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of unconjugated Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Despropylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
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
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose
32 secondary outcomes
Terminal half-life [t1/2] of unconjugated Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of unconjugated Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amounts of unconjugated Rotigotine excreted in urine [Ae]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal Clearance [CLR] of unconjugated Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of total Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of total Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance of total Rotigotine normalized by body weight [CL/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amount of total Rotigotine excreted into urine [Ae]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of total Rotigotine excreted into urine [fe (% of dose)]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal clearance [CLR] of total Rotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of total Despropylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of total Despropylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amount of total Despropylrotigotine excreted into urine [Ae]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal Clearance [CLR] of total Despropylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Terminal half-life [t1/2] of total Desthienylethylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Time of maximum concentration [tmax] of total Desthienylethylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Amount of total Desthienylethylrotigotine excreted into urine [Ae]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)]
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Renal clearance [CLR] of total Desthienylethylrotigotine
Time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rotigotine transdermal patch in people with Healthy, run by UCB BIOSCIENCES GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.