Text Size

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

This study has been completed.
Sponsor:
Collaborators:
Schwarz BioSciences GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01761526
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Rotigotine transdermal patch
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Parallel Group Trial to Evaluate the Pharmacokinetics and Safety / Tolerability of Single-Dose Treatment With Rotigotine Continuous Delivery System (10 cm2 / 4.5 mg) in Japanese and Caucasian Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Rotigotine
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma [Cmax] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma [Cmax] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma [Cmax] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Terminal half-life [t1/2] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Time of maximum concentration [tmax] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Amounts of unconjugated Rotigotine excreted in urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Renal Clearance [CLR] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Terminal half-life [t1/2] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Time of maximum concentration [tmax] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Total body clearance of total Rotigotine normalized by body weight [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Amount of total Rotigotine excreted into urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Fraction of total Rotigotine excreted into urine [fe (% of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Renal clearance [CLR] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Terminal half-life [t1/2] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Time of maximum concentration [tmax] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Amount of total Despropylrotigotine excreted into urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Renal Clearance [CLR] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Terminal half-life [t1/2] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Time of maximum concentration [tmax] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Amount of total Desthienylethylrotigotine excreted into urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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

  • Renal clearance [CLR] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    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


Enrollment: 50
Study Start Date: October 2002
Study Completion Date: December 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Drug: Rotigotine transdermal patch
Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
Other Name: Neupro
Experimental: Rotigotine in Caucasian
  • 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
Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
Other Name: Neupro

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761526

Locations
Germany
01
Neuss, Germany
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Schwarz BioSciences GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01761526     History of Changes
Other Study ID Numbers: SP717
Study First Received: January 3, 2013
Last Updated: January 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Rotigotine
Neupro
Japanese
Caucasian
 Male
Female
Single dose
Pharmacokinetics

Additional relevant MeSH terms:
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013