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Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03589066
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: LY03003 Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two different formulations of LY03003, i.e. Formulation A and Formulation B
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arm Intervention/treatment
Experimental: Formulation A
LY03003 28 mg intramuscular suspension, single dose, 1 day duration
Drug: LY03003
28 mg intramuscular suspension
Other Name: rotigotine

Experimental: Formulation B
LY03003 28 mg intramuscular suspension, single dose, 1 day duration
Drug: LY03003
28 mg intramuscular suspension
Other Name: rotigotine




Primary Outcome Measures :
  1. Cmax [ Time Frame: 22 days ]
    Maximum plasma concentration

  2. AUClast [ Time Frame: 22 days ]
    Area under the concentration-time curve up to the time of the last measurable concentration

  3. AUCinf [ Time Frame: 22 days ]
    Area under the concentration-time curve from time zero extrapolated to infinity


Secondary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22 ]
    Adverse events

  2. Frequency of serious adverse events [ Time Frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22 ]
    Serious adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589066


Locations
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Sponsors and Collaborators
Luye Pharma Group Ltd.
Investigators
Study Director: Kevin Booth, MD, DVM Luye Pharma Group Ltd.

Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT03589066     History of Changes
Other Study ID Numbers: LY03003/CT-USA-104
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luye Pharma Group Ltd.:
rotigotine
parkinson
parkinsons
intramuscular injection
UPDRS

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs