Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations

NCT02070796 | Completed Phase 1 DMC

• 1 other identifier: PD0011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to establish Bioequivalence (BE) of 2 different formulations of the 2 mg/24 hr (10 cm\^2) Rotigotine transdermal patches in Chinese subjects.

Conditions

Healthy

Keywords

Rotigotine; Transdermal Patch; Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC(0-t))

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application.

• Area under the plasma concentration-time curve from zero up to Infinity (AUC)

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

• The maximum plasma concentration of unconjugated Rotigotine (Cmax)

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

Secondary Outcomes (13)

• Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-t) norm (apparent dose))

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

• Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-t) norm (BW))

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

• Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUCnorm (apparent dose))

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

• Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUCnorm (BW))

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

• Maximum plasma concentration of unconjugated Rotigotine normalized by apparent dose (Cmax, norm (apparent dose))

  Blood samples will be taken predose, and at 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 16 hr, 24 hr (immediately prior to patch removal in the morning of Day 2), 25 hr, 26 hr, 28 hr, 30 hr, 32 hr, 36 hr, 40 hr, and 48 hr after patch application

Study Arms (2)

Treatment A - B

EXPERIMENTAL

Single application of the test transdermal patch (Treatment A, Rotigotine PR2.2.1) for 24 hours, followed by a Wash-Out Period of 7 days and a single application of the reference transdermal patch (Treatment B, Rotigotine PR2.1.1) for 24 hours.

Drug: Rotigotine PR2.2.1; Drug: Rotigotine PR2.1.1

Treatment B - A

ACTIVE COMPARATOR

Single application of the reference transdermal patch (Treatment B, Rotigotine PR2.1.1) for 24 hours, followed by a Wash-Out Period of 7 days and a single application of the test transdermal patch (Treatment A, Rotigotine PR2.2.1) for 24 hours.

Drug: Rotigotine PR2.2.1; Drug: Rotigotine PR2.1.1

Interventions

Rotigotine PR2.2.1 DRUG

Treatment A: Rotigotine Transdermal patch 2 mg/24 hr (10 cm\^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.

Treatment A - B; Treatment B - A

Rotigotine PR2.1.1 DRUG

Treatment B: Rotigotine Transdermal patch 2 mg/24 hr (10 cm\^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.

Treatment A - B; Treatment B - A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
• Subject is considered reliable and capable of adhering to the protocol, visit schedule, and patch application according to the judgment of the investigator
• Subject is willing and able to comply with all study requirements
• Subject is Chinese (with all 4 grandparents being of Chinese origin, as well), male, and aged between 18 and 40 years (inclusive)
• Subject is healthy (no clinically significant findings in any of the investigations at the Eligibility Assessment (EA))
• Subject has a body mass index between 19 kg/m² and 24 kg/m² (inclusive), and a body weight greater than or equal to 50 kg
• Subject agreed to practice a medically accepted method of contraception (eg, condom, spermicide) unless sexually abstinent for the duration of the study and up to 3 months after the final patch application

You may not qualify if:

• Subject has previously participated in this study or subject has previously been assigned to treatment in a Rotigotine study
• Subject has participated in another study of an Investigational Medicinal Product (IMP) (or a medical device) within the previous 3 months or is currently participating in another study of an IMP (or a medical device)
• Subject has a history of diagnosis, counseling, or treatment for chronic alcohol or drug abuse within the previous 2 years
• Subject has a known clinically significant allergy or known or suspected clinically significant drug hypersensitivity to any components of the IMP or comparable drugs that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subject has lifetime history of suicide attempt
• Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or has recently unresolved contact dermatitis
• Subject has an medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subject has a history or present condition of epilepsy and/or seizures
• Subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (1)

1

Hong Kong, 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

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

CN (1)