Parkinson DiseasePhase 1NCT03589066
Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease
A Phase 1 study testing LY03003 in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LY03003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2018to 31 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
MD Clinical
Hallandale, Florida, 33009
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- LY03003
- Keywords
- rotigotine, parkinson, parkinsons, intramuscular injection, UPDRS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03003Drug
Also called rotigotine
28 mg intramuscular suspension
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | LY03003 28 mg intramuscular suspension, single dose, 1 day duration Receives: Drug: LY03003 |
| Formulation B | Experimental | LY03003 28 mg intramuscular suspension, single dose, 1 day duration Receives: Drug: LY03003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 22 days
AUClast
Area under the concentration-time curve up to the time of the last measurable concentration
Measured: 22 days
AUCinf
Area under the concentration-time curve from time zero extrapolated to infinity
Measured: 22 days
Secondary outcomes (2)
Frequency of adverse events
Adverse events
Measured: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
Frequency of serious adverse events
Serious adverse events
Measured: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start15 May 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different formulations of LY03003, i.e. Formulation A and Formulation B
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Booth, MD, DVM, Study director, Luye Pharma Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589066
- Sponsor's protocol ID
- LY03003/CT-USA-104
- Status last verified
- Nov 2018
- First submitted
- 8 Jun 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03589066
- Acronym / sponsor ID
- LY03003/CT-USA-104
- Conditions
- Parkinson Disease
- Keywords
- rotigotine, parkinson, parkinsons, intramuscular injection, UPDRS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two different formulations of LY03003, i.e. Formulation A and Formulation B
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: LY03003LY03003 28 mg intramuscular suspension, single dose, 1 day duration |
| Formulation B | Experimental | Drug: LY03003LY03003 28 mg intramuscular suspension, single dose, 1 day duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY03003Also: rotigotine28 mg intramuscular suspension | Drug | Formulation A, Formulation B |
Primary outcome
Cmax
Time frame: 22 days
Maximum plasma concentration
AUClast
Time frame: 22 days
Area under the concentration-time curve up to the time of the last measurable concentration
AUCinf
Time frame: 22 days
Area under the concentration-time curve from time zero extrapolated to infinity
2 secondary outcomes
Frequency of adverse events
Time frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
Frequency of serious adverse events
Time frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Booth, MD, DVM study director
Luye Pharma Group Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY03003 in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 22 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.