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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ja

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

Detailed Summary:
Sponsor: UCB BIOSCIENCES GmbH

Current Primary Outcome:

  • 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 ]
    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 ]
    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 ]
    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 ]
    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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Terminal half-life [t1/2] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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 ]
      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-Dos

      Original Secondary Outcome: Same as current

      Information By: UCB Pharma

      Dates:
      Date Received: January 3, 2013
      Date Started: October 2002
      Date Completion:
      Last Updated: October 17, 2014
      Last Verified: January 2013