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

NCT ID: NCT01854216

Last Updated: 2014-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Rotigotine in Japanese subjects

Repeated-Dose application of 1,2, and 4 mg / 24 hours Rotigotine in healthy Japanese subjects; Transdermal patch over 24 hours

Group Type EXPERIMENTAL

Rotigotine transdermal patch 1mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours

Rotigotine transdermal patch 2 mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours

Rotigotine transdermal patch 4 mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours

Rotigotine in Caucasian subjects

Multiple-Dose application of 1, 2, and 4 mg / 24 hours Rotigotine in healthy Caucasian subjects; Transdermal patch over 24 hours

Group Type EXPERIMENTAL

Rotigotine transdermal patch 1mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours

Rotigotine transdermal patch 2 mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours

Rotigotine transdermal patch 4 mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours

Interventions

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Rotigotine transdermal patch 1mg / 24 hours

Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch 2 mg / 24 hours

Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours

Intervention Type DRUG

Rotigotine transdermal patch 4 mg / 24 hours

Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours

Intervention Type DRUG

Other Intervention Names

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Neupro Neupro Neupro

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB BIOSCIENCES GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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1

Neuss, , Germany

Site Status

Countries

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Germany

References

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Cawello W, Kim SR, Braun M, Elshoff JP, Masahiro T, Ikeda J, Funaki T. Pharmacokinetics, safety, and tolerability of rotigotine transdermal system in healthy Japanese and Caucasian subjects following multiple-dose administration. Eur J Drug Metab Pharmacokinet. 2016 Aug;41(4):353-62. doi: 10.1007/s13318-015-0273-6. Epub 2015 Mar 13.

Reference Type DERIVED
PMID: 25773763 (View on PubMed)

Other Identifiers

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SP0718

Identifier Type: -

Identifier Source: org_study_id

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