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