Safety and PK study of LY03003
- Conditions
- Parkinson's Disease
- Registration Number
- JPRN-jRCT2080224689
- Lead Sponsor
- Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 32
1.Capable of giving informed consent and complying with trial procedures including the ability to stay at return to the clinic for visits at the predetermined times on the prescribed schedule.
2.Have idiopathic Parkinson's Disease (i.e., without any other known or suspected cause of Parkinsonism) defined by the cardinal sign, bradykinesia, plus the presence of either static tremor or rigidity.
3.Male or female Japanese patient 20 years old or more at screening visit.
4.Mini Mental State Examination (MMSE) score 25 or more at screening visit.
5.Unified Parkinson's Disease Rating Scale (UPDRS) motor (Part III) score 10 or more but 42 or less at screening visit.
6.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.Highly effective methods of birth control 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 birth control method if the vasectomized partner is the sole sexual partner of the female participant and the vasectomized partner has received medical confirmation of surgical success. Highly effective methods of birth control must be used for at least 21 days prior to the first dose of study drug,throughout the trial,and for a minimum of 1 month after the end of the trial to minimize the risk of pregnancy. The contraceptive methods approved in Japan are an intrauterine contraceptive device (IUD),an intrauterine hormone release system (IUS),a vasectomy and an oral hormone contraceptive agent,which is progesterone or combined type with ovulation inhibiting action.
1.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).
2.History of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant.
3.Dementia, active psychosis or hallucinations, or clinically significant major depression requiring psychiatric interventions.
4.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 Columbia-Suicide Severity Rating Scale (C-SSRS).
5.With a history of symptomatic orthostatic hypotension or a decrease of 30 mmHg or more in systolic blood pressure (SBP) or decrease of 15 mmHg or more in diastolic blood pressure (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 the supine position at the Screening or enrollment Visit.
6.Therapy with a dopamine (DA) agonist either concurrently or within 28 days prior to the first dose of study drug.
7.Therapy with 1 or more of the following drugs either concurrently or within 28 days prior to the first dose of study drug: monoamine oxidase (MAO) - A inhibitors, DA releasing agents, DA modulating agents, DA antagonists, DA depleting antihypertensives, tricyclic antidepressants, neuroleptics, or other medications that may interact with DA function.
8.Monoamine oxidase (MAO) - B inhibitors, amantadine, anticholinergic agents unless the dose has been stable for at least 28 days prior to the first dose of study drug and is likely to remain stable for the duration of the trial.
9.Central nervous system (CNS) active therapy (e.g., sedatives, hypnotics, antidepressants, anxiolytics) unless the dose has been stable for at least 28 days prior to the first dose of study drug and is likely to remain stable for the duration of the trial.
10.History of known intolerance/hypersensitivity to antiemetics such as ondansetron, tropisetron, and glycopyrrolate.
11.Current diagnosis of asthma, epilepsy, history of seizures as an adult, lifetime history of stroke, or transient ischemic attack (TIA) within 1 year prior to the Screening Visit.
12.History of sleep attacks or narcolepsy.
13.Female patient who is pregnant or breastfeeding or of childbearing potential without adequate contraception (see Inclusion Criterion 6).
14.History of prescription drug abuse or illicit drug use, alcohol abuse, or tobacco use (more than 20 cigarettes per day) within 6 months prior to the Screening Visit or positive finding in drugs of abuse test or alcohol test.For the subject who has positive result in substance abuse test: If the investigator can rule out the possibility of substance abuse and the positive result can be attribute to the therapeutic drug in use. This subject can be enrolled with evidence from medical history and statement document from the investigator (the statement should including therapeutic drug name, disease, administration time and ingredients/ metabolite which lead to the positive result.) Or the subject should be excluded.
15.Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface Antigen (HBsAg), and hepatitis C antibodies.
16.Receipt of another investigational product within one mo
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>other<br>1.To assess the safety and tolerability of multiple intramuscular (IM) injections of LY03003 at doses of 14,28 and 56 mg/week in Japanese patients with Parkinson's disease (PD)<br>2.To characterize the pharmacokinetics (PK) of LY03003 following multiple IM injections in Japanese patients with Parkinson's disease
- Secondary Outcome Measures
Name Time Method bioavailability<br>other<br>1.To assess the relative bioavailability of LY03003 compared to rotigotine transdermal patch at steady state in Japanese patients with Parkinson's disease.<br>2.To characterize the dose proportionality of steady state rotigotine exposure after LY03003 IM injections (14, 28 and 56 mg/week) and rotigotine transdermal patch applications (4.5, 9 and 18 mg/day)