- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03589066
Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease
November 6, 2018 updated by: Luye Pharma Group Ltd.
An Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's Disease
This is a Phase 1, open-label, parallel-group study to evaluate rotigotine pharmacokinetics, safety and tolerability following a single intramuscular dose of one of two different formulations of LY03003 in patients with Parkinson's disease.
Study Overview
Detailed Description
This study is designed to evaluate and compare the rotigotine pharmacokinetic profile of a single 28 mg intramuscular dose of LY03003 Formulation A and LY03003 Formulation B. The secondary objective of the trial is to evaluate the safety and tolerability of LY03003 Formulation A and LY03003 Formulation B following a single 28 mg IM dose administered to patients with Parkinson's Disease.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Hallandale Beach, Florida, United States, 33009
- MD Clinical
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Georgia
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Atlanta, Georgia, United States, 30331
- Atlanta Center for Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Capable of giving informed consent and complying with trial procedures including the ability to stay at/return to the CRU for visits at the predetermined times on the prescribed schedule.
- Has idiopathic Parkinson's Disease (i.e., without any other known or suspected cause of Parkinsonism) defined by the cardinal signs, bradykinesia, plus the presence of ≥1 of the following: resting tremor, rigidity, or impairment of postural reflexes.
- Male or female patient ≥18 years old with BMI of 18.5 to 32 kg/m2, inclusive, and body weight ≥50 kg at Screening.
- MMSE score ≥25 at Screening.
- UPDRS motor (Part III) score ≥ 10 but ≤ 42 at Screening.
- All female patients (childbearing potential and non-childbearing potential) must have a negative serum pregnancy test result at Screening. In addition, female patients 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 occlusion) based on patient report, or (iii) if of childbearing potential, practicing or agree to practice a highly effective method of contraception.
Exclusion Criteria:
- Atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, flunarizine), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., progressive Supranuclear Palsy).
- History of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant.
- Dementia, active psychosis or hallucinations, or clinically significant major depression requiring psychiatric interventions.
- Lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the C-SSRS.
- History of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in SBP or decrease of ≥10 mmHg in DBP when changing from supine to 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 the Screening Visit.
- Therapy with a dopamine (DA) agonist either concurrently or within 21 days prior to study drug dosing.
- Therapy with 1 or more of the following drugs either concurrently or within 21 days prior to study drug dosing: monoamine oxidase inhibitors, DA releasing agents, DA modulating agents, DA antagonists, DA depleting antihypertensives, tricyclic antidepressants, neuroleptics, or other medications that may interact with DA function.
- Current diagnosis of epilepsy, history of seizures as an adult, lifetime history of stroke, or transient ischemic attack (TIA) within 1 year prior to the Screening Visit.
- Female patient who is pregnant or breastfeeding or of childbearing potential without adequate contraception
- History of prescription drug abuse or illicit drug use, alcohol abuse, or tobacco use within 6 months prior to the Screening Visit or positive finding in drugs of abuse test, nicotine test, or alcohol test.
- Any other clinically relevant hepatic, renal, hematologic, and/or cardiac dysfunction, or other medical condition, or clinically significant laboratory abnormality that would interfere with the patient's safety or trial outcome in the judgment of the Investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Formulation A
LY03003 28 mg intramuscular suspension, single dose, 1 day duration
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28 mg intramuscular suspension
Other Names:
|
Experimental: Formulation B
LY03003 28 mg intramuscular suspension, single dose, 1 day duration
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28 mg intramuscular suspension
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 22 days
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Maximum plasma concentration
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22 days
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AUClast
Time Frame: 22 days
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Area under the concentration-time curve up to the time of the last measurable concentration
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22 days
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AUCinf
Time Frame: 22 days
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Area under the concentration-time curve from time zero extrapolated to infinity
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22 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events
Time Frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
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Adverse events
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screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
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Frequency of serious adverse events
Time Frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
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Serious adverse events
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screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kevin Booth, MD, DVM, Luye Pharma Group Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2018
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
June 8, 2018
First Submitted That Met QC Criteria
July 16, 2018
First Posted (Actual)
July 17, 2018
Study Record Updates
Last Update Posted (Actual)
November 8, 2018
Last Update Submitted That Met QC Criteria
November 6, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Rotigotine
Other Study ID Numbers
- LY03003/CT-USA-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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