Clinical trial NCT03589066: Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: rotigotine
parkinson
parkinsons
intramuscular injection
UPDRS
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different formulations of LY03003, i.e. Formulation A and Formulation B
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cmax
timeFrame: 22 days
measure: AUClast
timeFrame: 22 days
measure: AUCinf
timeFrame: 22 days
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
measure: Frequency of serious adverse events
timeFrame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
Other outcomes:
Locations:
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
Study officials:
affiliation: Luye Pharma Group Ltd.
name: Kevin Booth, MD, DVM
role: STUDY_DIRECTOR
References: