NCT01854216

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
Last Updated

October 20, 2014

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

May 10, 2013

Last Update Submit

October 17, 2014

Conditions

Healthy

Keywords

RotigotineNeuproJapaneseCaucasianMaleFemaleSingle dosePharmacokinetics

Outcome Measures

Primary Outcomes (12)

  • Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss)

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of unconjugated Rotigotine in plasma at steady-state (Cmax,ss)

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval (AUCtau,ss)

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of total Rotigotine in plasma at steady-state (Cmax,ss)

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of total Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

Secondary Outcomes (8)

  • Terminal half-life (t1/2) of unconjugated Rotigotine in steady-state

    Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours

  • Time of maximum concentration (tmax) of unconjugated Rotigotine in steady-state (tmax,ss)

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Apparent total body clearance of unconjugated Rotigotine normalized by Body Weight (CL/f/BW)

    Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  • Apparent volume of distribution of unconjugated Rotigotine normalized by Body Weight (Vz/f/BW)

    Blood sampling at 0 hours (predose), 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

  • Terminal half-life (t1/2) of total Rotigotine in steady-state

    Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours

  • +3 more secondary outcomes

Study Arms (2)

Rotigotine in Japanese subjects

EXPERIMENTAL

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

Drug: Rotigotine transdermal patch 1mg / 24 hoursDrug: Rotigotine transdermal patch 2 mg / 24 hoursDrug: Rotigotine transdermal patch 4 mg / 24 hours

Rotigotine in Caucasian subjects

EXPERIMENTAL

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

Drug: Rotigotine transdermal patch 1mg / 24 hoursDrug: Rotigotine transdermal patch 2 mg / 24 hoursDrug: Rotigotine transdermal patch 4 mg / 24 hours

Interventions

Rotigotine transdermal patch 1mg / 24 hoursDRUG

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

Also known as: Neupro
Rotigotine in Caucasian subjectsRotigotine in Japanese subjects
Rotigotine transdermal patch 2 mg / 24 hoursDRUG

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

Also known as: Neupro
Rotigotine in Caucasian subjectsRotigotine in Japanese subjects
Rotigotine transdermal patch 4 mg / 24 hoursDRUG

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

Also known as: Neupro
Rotigotine in Caucasian subjectsRotigotine in Japanese subjects

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1

Neuss, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25773763DERIVED

MeSH Terms

Interventions

rotigotine

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 15, 2013

Study Start

December 1, 2002

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

October 20, 2014

Record last verified: 2013-05

Locations

DE(1)