Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects

NCT01675024 | Completed Phase 1

• 1 other identifier: SP0913
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine after single and multiple doses of Rotigotine transdermal patch, and also to investigate the safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.

Conditions

Healthy

Keywords

Neupro, Pharmacokinetics, healthy Chinese subjects

Outcome Measures

Primary Outcomes (8)

• Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1)

  Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1

  Period 1; Day 1 to Day 3 of study

• Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2)

  Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12

  Period 2; Day 7 to Day 14 of study

• Plasma concentrations of total Rotigotine for single-dose application (Period 1)

  Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1

  Period 1; Day 1 to Day 3 of study

• Plasma concentrations of total Rotigotine for multiple-dose application (Period 2)

  Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12

  Period 2; Day 7 to Day 14 of study

• Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC 0-tz) for single-dose application (Period 1)

  Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1

  Period 1; Day 1 to Day 3 of study

• Maximum plasma concentration (Cmax) for single-dose application (Period 1)

  Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1

  Period 1; Day 1 to Day 3 of study

• Area under the plasma concentration-time curve from zero to 24 hours at steady state (AUC(0-24h),ss) for multiple-dose application (Period 2)

  Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12

  Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure

• Maximum plasma concentration at steady state (Cmax,ss) for multiple-dose application (Period 2)

  Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12

  Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure

Secondary Outcomes (35)

• Terminal half-life (t½) for single-dose application (Period 1)

  Period 1; Day 1 to Day 3 of study

• Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1)

  Period 1; Day1 to Day 3 of study

• Lag time until first concentration ≥ limit of quantitation (LOQ) (tlag) for single-dose application (Period 1)

  Period 1; Day 1 to Day 3 of study

• Maximum plasma concentration normalized by Body Weight (kg) (Cmax, norm (BW)) for single-dose application (Period 1)

  Period 1; Day 1 to Day 3 of study

• Maximum plasma concentration normalized by apparent dose (mg)(Cmax, norm (apparent dose)) for single-dose application (Period 1)

  Period 1; Day 1 to Day 3 of study

Study Arms (2)

Rotigotine, Period 1

EXPERIMENTAL

In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.

Drug: Rotigotine, Period 1

Rotigotine, Period 2

EXPERIMENTAL

In Period 2 (Day 7 to Day 14) all 24 subjects will receive 2 mg / 24 hours for 3 days then 4 mg / 24 hours for 3 days.

Drug: Rotigotine, Period 2

Interventions

Rotigotine, Period 1 DRUG

Formulation: transdermal Dosage: 2 mg / 24 hours once at Day 2 Frequency: once every 24 hours Duration: from Day 1 to Day 3

Also known as: Neupro

Rotigotine, Period 1

Rotigotine, Period 2 DRUG

Formulation: transdermal Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12 Frequency: once every 24 hours Duration: from Day 1 to Day 3

Also known as: Neupro

Rotigotine, Period 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese subjects
• Healthy volunteers with normal body weight, female subject is willing to use a double contraceptive barrier method or an oral hormonal contraceptive during the entire study

You may not qualify if:

• Previously participated in any Rotigotine study or participated in another clinical study for an investigational drug
• History of drug or alcohol abuse within the last 2 years
• Suicide attempt or suicidal ideation in the past 6 months
• Transient ischemic attack or stroke within the last 12 months
• Current condition of epilepsy and / or seizures
• History of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
• History or present condition of an atopic or eczematous dermatitis, psoriasis and / or an active skin disease
• Female subject is pregnant or lactating
• Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's wellbeing or ability to participate in this study
• Subject has a QTcB (QT interval corrected for heart rate according to Bazett's formula) interval of ≥ 450 ms for female or ≥ 430 ms for male
• Subject has a relevant hepatic dysfunction (total bilirubin \> 2 mg / dL or alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] greater than 2 times the upper limit of the normal reference range)
• Subject has tested positive for human immunodeficiency virus antibodies (HIV)-1 / 2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)
• Subject has a positive urine drug screen and / or alcohol breath test on Day 1
• Subject has made a blood donation or had a comparable blood loss (\> 400 mL)
• Subject smokes or has done so within 6 months prior to Eligibility Assessment (EA)

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Unknown Facility

Shanghai, China

Location

Related Publications (1)

• Liu Y, Tomlinson B, Guo J, Asgharnejad M, Bauer L, Surmann E, Guo X, Elshoff JP. Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects. Clin Ther. 2018 Jul;40(7):1108-1121.e8. doi: 10.1016/j.clinthera.2018.05.009.

  PMID: 30098648 DERIVED

MeSH Terms

Interventions

rotigotine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

CN (1)