Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

NCT01059903 | Completed Phase 1 Results

• 1 other identifier: SP0987
• Study Type: interventional
• Target: 50
• 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 two Rotigotine patches of two different formulations

Conditions

Healthy Volunteers

Keywords

Rotigotine; Neupro®; Transdermal Patch

Outcome Measures

Primary Outcomes (3)

• AUC(0-tz) of Unconjugated Rotigotine

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

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

• Cmax of Unconjugated Rotigotine

  The Cmax is the maximum plasma concentration.

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

• AUC(0- ∞) of Unconjugated Rotigotine

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

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Secondary Outcomes (12)

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

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

• AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

• AUC(0- ∞) Norm (Apparent Dose)

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

• AUC(0- ∞) Norm (Body Weight)

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

• Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine

  0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Study Arms (2)

Rotigotine PR2.2.1 first

EXPERIMENTAL

Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days

Drug: Rotigotine transdermal patch

Rotigotine PR2.1.1 first

EXPERIMENTAL

Rotigotine transdermal patch 4.5 mg/10 cm\^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10 cm\^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days

Drug: Rotigotine transdermal patch

Interventions

Rotigotine transdermal patch DRUG

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

Also known as: Neupro®

Rotigotine PR2.1.1 first; Rotigotine PR2.2.1 first

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/m\^2 (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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, Germany

Location

Related Publications (1)

• Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23.

  PMID: 24006953 DERIVED

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: January 28, 2010
• First Posted: February 1, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 22, 2012
• Results First Posted: March 3, 2011

Record last verified: 2012-05

Locations

DE (1)