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

NCT ID: NCT01761526

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2002-12-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Rotigotine in Healthy Japanese

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

Group Type: EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type: DRUG

Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)

Rotigotine in Caucasian

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

Group Type: EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type: DRUG

Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)

Interventions

Rotigotine transdermal patch

Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)

Intervention Type: DRUG

Other Intervention Names

Neupro

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Schwarz BioSciences GmbH

UNKNOWN

Sponsor Role: collaborator

Alfred-Nobel-Str. 10

UNKNOWN

Sponsor Role: collaborator

40789 Monheim am Rhein

UNKNOWN

Sponsor Role: collaborator

UCB BIOSCIENCES GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

01

Neuss, , Germany

Countries

Germany

Other Identifiers

SP0717

Identifier Type: -

Identifier Source: org_study_id