NCT01761526

Brief Summary

To investigate the 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
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_1 healthy

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

October 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

October 20, 2014

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

January 3, 2013

Last Update Submit

October 17, 2014

Conditions

Healthy

Keywords

RotigotineNeuproJapaneseCaucasianMaleFemaleSingle dosePharmacokinetics

Outcome Measures

Primary Outcomes (15)

  • Area under the concentration-time curve (AUC) from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of unconjugated Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized [AUC (0-t)norm] of unconjugated Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of unconjugated Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of total Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Despropylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Despropylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of total Despropylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Desthienylethylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Desthienylethylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine

    Blood sampling at 0 hours (Pre-Dose), 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, and 60 hours Post-Dose

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

Secondary Outcomes (32)

  • Terminal half-life [t1/2] of unconjugated Rotigotine

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Time of maximum concentration [tmax] of unconjugated Rotigotine

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW]

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW]

    From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose

  • +27 more secondary outcomes

Study Arms (2)

Rotigotine in Healthy Japanese

EXPERIMENTAL

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

Drug: Rotigotine transdermal patch

Rotigotine in Caucasian

EXPERIMENTAL

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

Drug: Rotigotine transdermal patch

Interventions

Rotigotine transdermal patchDRUG

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

Also known as: Neupro
Rotigotine in CaucasianRotigotine in Healthy Japanese

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, 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

01

Neuss, Germany

Location

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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 4, 2013

Study Start

October 1, 2002

Primary Completion

October 1, 2002

Study Completion

December 1, 2002

Last Updated

October 20, 2014

Record last verified: 2013-01

Locations

DE(1)