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

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Rotigotine transdermal patch 1mg / 24 hours

Drug: Rotigotine transdermal patch 4 mg / 24 hours

Drug: Rotigotine transdermal patch 2 mg / 24 hours

Study type

Interventional

Funder types

Industry

Identifiers

NCT01854216

SP0718

Details and patient eligibility

About

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

Enrollment

26 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, 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