Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease

Sponsor

Luye Pharma Group Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03589066

Collaborator

(none)

Enrollment

Locations

Arms

5.6

Actual Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two different formulations of LY03003, i.e. Formulation A and Formulation BTwo 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 :

Oct 31, 2018

Actual Study Completion Date :

Oct 31, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Formulation A

LY03003 28 mg intramuscular suspension, single dose, 1 day duration

Drug: LY03003

28 mg intramuscular suspension

Other Names:

rotigotine

Experimental: Formulation B

LY03003 28 mg intramuscular suspension, single dose, 1 day duration

Drug: LY03003

28 mg intramuscular suspension

Other Names:

rotigotine

Outcome Measures

Primary Outcome Measures

Cmax [22 days]
Maximum plasma concentration
AUClast [22 days]
Area under the concentration-time curve up to the time of the last measurable concentration
AUCinf [22 days]
Area under the concentration-time curve from time zero extrapolated to infinity

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.