Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rotigotine transdermal patch

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01761526

SP0717

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Rotigotine in Healthy Japanese

Experimental group

Description:

* Rotigotine transdermal patch * Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects * Transdermal patch over 24 hours

Treatment:

Drug: Rotigotine transdermal patch

Rotigotine in Caucasian

Experimental group

Description:

* Rotigotine transdermal patch * Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects * Transdermal patch over 24 hours

Treatment:

Drug: Rotigotine transdermal patch