Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

NCT00957944 | Completed Phase 1 Results

• 1 other identifier: SP0957
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.

Conditions

Healthy Volunteers

Keywords

Rotigotine; Neupro®

Outcome Measures

Primary Outcomes (3)

• AUC(0-tz) of Unconjugated Rotigotine

  The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

• Cmax of Unconjugated Rotigotine

  The Cmax is the maximum plasma concentration.

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

• AUC(0-∞) of Unconjugated Rotigotine

  The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Secondary Outcomes (12)

• AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

• AUC(0-tz) Norm (BW) of Unconjugated Rotigotine

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

• AUC(0-∞) Norm (Apparent Dose)

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

• AUC(0-∞) Norm (BW)

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

• Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine

  Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Study Arms (2)

Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)

EXPERIMENTAL

Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days

Drug: rotigotine transdermal patch (Neupro®)

Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)

EXPERIMENTAL

Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days

Drug: rotigotine transdermal patch (Neupro®)

Interventions

rotigotine transdermal patch (Neupro®) DRUG

Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Also known as: Neupro®

Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND); Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, white, male volunteers between 18 and 55 years of age (inclusive)
• BMI between 19 and 28 kg/m² (inclusive)

You may not qualify if:

• previous participation in a clinical study with Rotigotine
• history or current condition of epilepsy and/or seizures
• known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
• history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
• history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
• clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations
• positive HIV, hepatitis B or C test or positive alcohol or drug test
• relevant hepatic or renal dysfunction
• intake of medication that might interfere with the test drug within 2 weeks prior to dosing
• thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Unknown Facility

Neuss, North Rhine-Westphalia, Germany

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

rotigotine

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

Study Officials

• UCB Clinical Trial Call center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 27, 2014
• Results First Posted: September 22, 2010

Record last verified: 2012-04

Locations

DE (1)