A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro

NCT03733561 | Completed Phase 1 FDA Drug

• 1 other identifier: LY03003/CT-USA-105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, single center study to assess pharmacokinetic profiles of rotigotine after single dose of LY03003 and daily patch application of Neupro in Healthy Volunteers

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• CMax

  34 days

Secondary Outcomes (1)

• Adverse Events

  34 days

Study Arms (2)

LY03003

EXPERIMENTAL

LY03003

Drug: LY03003

Neupro transdermal patch

ACTIVE COMPARATOR

Neupro transdermal 4 mg patch

Drug: Neupro 4Mg/24Hr Transdermal Patch

Interventions

LY03003 DRUG

LY03003 (rotigotine extended release microspheres for intramuscular \[IM\] injection)

LY03003

Neupro 4Mg/24Hr Transdermal Patch DRUG

neupro patch

Neupro transdermal patch

Eligibility Criteria

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

You may qualify if:

• Willing and capable of giving informed consent;
• Between the ages of 18 and 45 years old, inclusive;
• Healthy, per investigator judgment, based on detailed medical history, clinical laboratory safety tests, vital signs, full physical examination, and ECG;
• Nonsmoker defined as not having smoked or used any form of tobacco within 6 months before screening;
• BMI between 18.5 and 30 kg/m2, inclusive, and body weight ≥50 kg at screening;
• Willing and able to comply with study procedures, adhere to study restriction, and stay at the CRU during in-patient stays required by the protocol;
• All female subjects (childbearing potential and non-childbearing potential) must have a negative serum pregnancy test result at screening. In addition, female subjects must meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion) based on subject report, or (iii) if of childbearing potential and heterosexually active, practicing or agree to practice a highly effective method of contraception. Highly effective methods of contraception include an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), and contraceptives (oral, skin patches, or implanted or injectable products) using combined or progestogen-only hormonal contraception associated with inhibition of ovulation. A vasectomized male partner is an acceptable contraception method if the vasectomized partner is the sole sexual partner of the female subject and the vasectomized partner has received medical confirmation of surgical success. Highly effective methods of contraception must be used for at least 21 days prior to study drug dosing, throughout the study, and for a minimum of 1 month after the end of the study to minimize the risk of pregnancy.
• Sexually active, fertile, male patients must be willing to use acceptable contraception methods throughout the study and for at least 1 month after the end of the study if their partners are of childbearing potential.

You may not qualify if:

• History of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when changing from a supine to a standing position after having been in the supine position for at least 5 minutes or SBP less than 105 mmHg in a supine position at screening;
• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders, and/or drug hypersensitivity;
• History of epilepsy, seizures as an adult, lifetime history of stroke, or transient ischemic attack (TIA) within 1 year prior to screening;
• History of sleep attacks or narcolepsy;
• Known or suspected malignancy within 5 years with the exception of treated and cured basal cell carcinoma (skin), squamous cell carcinoma (skin), or in-situ cervical carcinoma;
• Positive blood screen for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• Positive pregnancy test result or plan to become pregnant if female;
• Hospital admission or major surgery within 30 days prior to screening;
• Receipt of another investigational product within one month or 5 half-lives of the other investigational product, whichever is longer, before study drug administration in this study.
• History of prescription drug abuse or any illicit drug use within 6 months prior to screening;
• History of alcohol abuse according to medical history within 6 months prior to screening;
• Positive screen for alcohol or drugs of abuse;
• Unwillingness or inability to comply with food and beverage restrictions during study participation;
• Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
• Use of prescription or over-the-counter (OTC) medications and/or herbal supplements (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at \<3 g/day is permitted until 24 hours prior to dosing);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Pharmaron CPC, Inc.

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Paul Rivellese

  Sponsor GmbH

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: November 9, 2018
• Primary Completion: December 23, 2018
• Study Completion: December 23, 2018
• Last Updated: April 2, 2021

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)