Parkinson DiseasePhase 1NCT04384666
A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers
A Phase 1 study testing LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) and Neupro 4 mg / 24 Hr. Transdermal Patch in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 1 site in United States.
Trial summary
This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment sequences. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) and Neupro 4 mg / 24 Hr. Transdermal Patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2020to 10 Aug 2020
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and capable of giving informed consent;
- Between the ages of 18 and 45 years old, inclusive;
- Healthy, per investigator's judgment, based on detailed medical history, clinical laboratory safety tests, vital signs, full physical examination, and ECG;
- Nonsmoker defined as not having smoked or used any form of tobacco within 6 months before screening;
- BMI between 18.5 and 30 kg/m2, inclusive, and body weight ≥50 kg at screening;
- Willing and able to comply with study procedures, adhere to study restrictions, and stay at the CRU during in-subject stays required by the protocol;
- All female subjects (childbearing potential and non-childbearing potential) must have a negative serum pregnancy test result at screening. In addition, female subjects 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 ligation/occlusion) based on subject report, or (iii) if of childbearing potential and heterosexually active, practicing or agree to practice a highly effective method of contraception. Highly effective methods of contraception 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 contraception method if the vasectomized partner is the sole sexual partner of the female subject and the vasectomized partner has received medical confirmation of surgical success. Highly effective methods of contraception must be used for at least 21 days prior to study drug dosing, throughout the study, and for another 90 days after the end of the study to minimize the risk of pregnancy.
- All male subjects must be willing to use a condom in combination with another acceptable form of contraception (such as partner's use of a cap, diaphragm, sponge, spermicide, or hormonal contraception. Of note, male and female condom combination is NOT acceptable)during any sexual activity (e.g. vaginal, anal, oral) with women with childbearing potential (WOCBP) even if the subjects have undergone a successful vasectomy or if their partner is already pregnant or breastfeeding, from study drug dosing, throughout the study, and for another 90 days after the end of study.
Who cannot join
- History of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when changing from a supine to a 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 screening and Baseline;
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders, and/or drug hypersensitivity;
- History of epilepsy, seizures as an adult, lifetime history of stroke, or transient ischemic attack (TIA) within 1 year prior to screening and Baseline;
- History of sleep attacks or narcolepsy;
- Known or suspected malignancy within 5 years with the exception of treated and cured basal cell carcinoma (skin), squamous cell carcinoma (skin), or in-situ cervical carcinoma;
- Positive blood screen for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
Show all 24Show fewer
- Positive pregnancy test result or plan to become pregnant if female;
- Female who is pregnant or breastfeeding or of childbearing potential without adequate contraception (see Inclusion Criterion 7);
- Hospital admission or major surgery within 30 days prior to screening and Baseline;
- Receipt of another investigational product within one month or 5 half-lives of the other investigational product, whichever is longer, before study drug administration in this study.
- Presence of ink tattoos of any kind in any of the designated patch application sites.
- History of prescription drug abuse or any illicit drug use within 6 months prior to screening and Baseline;
- History of alcohol abuse according to medical history within 6 months prior to screening and Baseline;
- Positive screen for alcohol, drugs of abuse and cotinine;
- Unwillingness or inability to comply with food and beverage restrictions during study participation;
- Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening and Baseline;
- Use of prescription or over-the-counter (OTC) medications and/or herbal supplements (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at <3 g/day is permitted until 24 hours prior to dosing);
- Inability to tolerate study drug in any prior rotigotine or LY03003 trial or intolerance or hypersensitivity to rotigotine or any excipients or diluents (Poly (lactide-co-glycolide) [PLGA], carboxymethylcellulose sodium [SCMC], stearic acid, or mannitol);
- History of known intolerance/hypersensitivity to antiemetics such as ondansetron, tropisetron, and glycopyrrolate;
- History of suicide attempt in the past 6 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;
- Unwillingness of male participants to use appropriate contraceptive measures (see Inclusion Criteria 8) if engaging in sexual intercourse with a female partner of childbearing potential throughout the study and for at least 1 month after the end of the study, plus an additional 60 days.
- Unwillingness to refrain from sexual intercourse with pregnant or lactating women throughout the study and for at least 1 month after the end of the study;
- 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 subject's safety or study outcome in the judgment of the investigator.
- A lifetime history of bipolar I disorder, bipolar II disorder, cyclothymia or other specified bipolar and related disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84124
About this study
This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment sequences.
Read the detailed description
Sequence 1
Period 1:
Subjects will check into the clinical research unit (CRU) on Day 0. On Day 1, subjects will receive the first 4 mg NEUPRO® patch in the morning. On Days 2 to 7, subjects will receive a 4- mg NEUPRO® patch every 24 hours (+/- 30 minutes) on one of the 7 designated patch application sites (see Section 12.2). On Day 1, serial PK samples will be collected within 30 minutes prior to patch application and 2, 4, 8, 12, 16, 20 hours post patch application. On Days 2, 3, 4, 5 and 6, one PK sample will be collected pre-patch (<30 minutes pre-patch) application only. On Day 7, the subjects will receive the NEUPRO® patch and serial PK samples will be collected pre-patch (<30 mins pre-patch) application and at 2, 4, 6, 8, 12, 16, 20, 24, 26, 28, 30, 33, 36, and 48 hours post-patch application Subject will stay at CRU till Day 14 to complete the End of Treatment ( EOT) procedures and prepare for the LY03003 treatment in Period 2 on the next day.
Period 2:
On Day 1 in the morning, subjects will receive a single-dose IM injection of 28 mg LY03003. Serial PK samples will be collected within 30 minutes pre-dosing and at 0.5, 1, 6, and 12 hours post dosing on Day 1. On Days 2 to Day 8, Day 10, Day 12, Day 15, Day 17, and Day 22, one single post-dose PK sample will be collected at the following corresponding hours: 24, 48, 72, 96, 120, 144, 168, 216, 264, 336, 384, and 504 hours post dosing. Subjects will stay at CRU till Day 22 to have PK collected and EOT activities completed. Subjects will be discharged on the same day. A 7-day safety follow-up period will be followed with a call on Day 29.
Sequence 2 Period 1 Subjects will check into the CRU on Day 0. In the morning of Day 1, subjects will receive a single-dose IM injection of 28 mg LY03003. Serial PK samples will be collected within 30 minutes pre-dosing and at 0.5, 1, 6 and 12 hours post dosing on Day 1. On Days 2 to Day 8, Day 10, Day 12, and Day 15, Day 17, and Day 22, one single postdose PK sample will be collected at the following corresponding hours: 24, 48, 72, 96, 120, 144, 168, 216, 264, 336, 384, and 504 hours post dosing. On Day 22, Subjects will have PK samples collected and EOT activities completed. Subjects will stay at the CRU until Day 29 and complete a 7-day washout period and to prepare for NEUPRO® patch treatment in Period 2 on the next day.
Period 2 On Day 1, subjects will receive the first 4 mg NEUPRO® patch in the morning. On Days 2 to 7, subjects will receive a 4- mg NEUPRO® patch every 24 hours (+/- 30 mins) on one of the 7 designated patch application sites (see Section 12.2). On Day 1, serial PK samples will be collected within 30 minutes prior to patch application and 2,4, 8, 12, 16 and 20 hours post patch application. On Days 2, 3, 4, 5 and 6, one PK sample will be collected pre-patch (<30 minutes pre-patch) application only. On Day 7, the subjects will receive the NEUPRO® patch and serial PK samples will be collected pre-patch (<30 minutes pre-patch) application and at 2, 4, 6, 8, 12, 16, 20, 24, 26, 28, 30, 33, 36, and 48 hours post-patch application. Subjects will stay at CRU and continue the safety follow-up period until Day14. On Day 14, subjects will complete EOT activities, followed by being discharged from the study on the same day.
- Conditions
- Parkinson Disease
- Being tested
- LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection), Neupro 4 mg / 24 Hr. Transdermal Patch
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)Drug
LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)
Neupro 4 mg / 24 Hr. Transdermal PatchOther
Neupro 4 mg /24 Hr. Transdermal Patch
| Study group | Role | What they receive |
|---|---|---|
| LY03003 | Experimental | LY03003 28 mg Receives: Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) |
| Neupro 4Mg/24Hr Transdermal Patch | Active comparator | Neupro 4 mg / 24 Hr. Transdermal Patch Receives: Other: Neupro 4 mg / 24 Hr. Transdermal Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 34 days
Secondary outcomes (1)
Adverse Events
Measured: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start2 Jun 2020
- Primary completion5 Aug 2020
- Study completion10 Aug 2020
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, open-label, 2-sequence, 2-treatment cross-over study to evaluate the rotigotine PK profiles after a single dose of 28 mg LY03003 IM injection and 7 days of 4 mg NEUPRO® patch q24h in healthy subjects. Subjects will be screened according to the inclusion and exclusion criteria (Days -28 to -1) prior to randomization. Each subject will be randomized 1:1 to 1 of the 2 treatment sequences and will participate in 2 treatment periods.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahad Sabet, MD, Principal investigator, Pharmaceutical Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384666
- Sponsor's protocol ID
- LY03003/CT-USA-106
- Status last verified
- Oct 2020
- First submitted
- 8 May 2020
- Last updated
- 14 Oct 2020
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04384666
- Acronym / sponsor ID
- LY03003/CT-USA-106
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 12 May 2020 (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 randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1 of the 2 treatment sequences.
Detailed description
Sequence 1
Period 1:
Subjects will check into the clinical research unit (CRU) on Day 0. On Day 1, subjects will receive the first 4 mg NEUPRO® patch in the morning. On Days 2 to 7, subjects will receive a 4- mg NEUPRO® patch every 24 hours (+/- 30 minutes) on one of the 7 designated patch application sites (see Section 12.2). On Day 1, serial PK samples will be collected within 30 minutes prior to patch application and 2, 4, 8, 12, 16, 20 hours post patch application. On Days 2, 3, 4, 5 and 6, one PK sample will be collected pre-patch (<30 minutes pre-patch) application only. On Day 7, the subjects will receive the NEUPRO® patch and serial PK samples will be collected pre-patch (<30 mins pre-patch) application and at 2, 4, 6, 8, 12, 16, 20, 24, 26, 28, 30, 33, 36, and 48 hours post-patch application Subject will stay at CRU till Day 14 to complete the End of Treatment ( EOT) procedures and prepare for the LY03003 treatment in Period 2 on the next day.
Period 2:
On Day 1 in the morning, subjects will receive a single-dose IM injection of 28 mg LY03003. Serial PK samples will be collected within 30 minutes pre-dosing and at 0.5, 1, 6, and 12 hours post dosing on Day 1. On Days 2 to Day 8, Day 10, Day 12, Day 15, Day 17, and Day 22, one single post-dose PK sample will be collected at the following corresponding hours: 24, 48, 72, 96, 120, 144, 168, 216, 264, 336, 384, and 504 hours post dosing. Subjects will stay at CRU till Day 22 to have PK collected and EOT activities completed. Subjects will be discharged on the same day. A 7-day safety follow-up period will be followed with a call on Day 29.
Sequence 2 Period 1 Subjects will check into the CRU on Day 0. In the morning of Day 1, subjects will receive a single-dose IM injection of 28 mg LY03003. Serial PK samples will be collected within 30 minutes pre-dosing and at 0.5, 1, 6 and 12 hours post dosing on Day 1. On Days 2 to Day 8, Day 10, Day 12, and Day 15, Day 17, and Day 22, one single postdose PK sample will be collected at the following corresponding hours: 24, 48, 72, 96, 120, 144, 168, 216, 264, 336, 384, and 504 hours post dosing. On Day 22, Subjects will have PK samples collected and EOT activities completed. Subjects will stay at the CRU until Day 29 and complete a 7-day washout period and to prepare for NEUPRO® patch treatment in Period 2 on the next day.
Period 2 On Day 1, subjects will receive the first 4 mg NEUPRO® patch in the morning. On Days 2 to 7, subjects will receive a 4- mg NEUPRO® patch every 24 hours (+/- 30 mins) on one of the 7 designated patch application sites (see Section 12.2). On Day 1, serial PK samples will be collected within 30 minutes prior to patch application and 2,4, 8, 12, 16 and 20 hours post patch application. On Days 2, 3, 4, 5 and 6, one PK sample will be collected pre-patch (<30 minutes pre-patch) application only. On Day 7, the subjects will receive the NEUPRO® patch and serial PK samples will be collected pre-patch (<30 minutes pre-patch) application and at 2, 4, 6, 8, 12, 16, 20, 24, 26, 28, 30, 33, 36, and 48 hours post-patch application. Subjects will stay at CRU and continue the safety follow-up period until Day14. On Day 14, subjects will complete EOT activities, followed by being discharged from the study on the same day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, open-label, 2-sequence, 2-treatment cross-over study to evaluate the rotigotine PK profiles after a single dose of 28 mg LY03003 IM injection and 7 days of 4 mg NEUPRO® patch q24h in healthy subjects. Subjects will be screened according to the inclusion and exclusion criteria (Days -28 to -1) prior to randomization. Each subject will be randomized 1:1 to 1 of the 2 treatment sequences and will participate in 2 treatment periods.
| Arm | Type | Receives |
|---|---|---|
| LY03003 | Experimental | Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)LY03003 28 mg |
| Neupro 4Mg/24Hr Transdermal Patch | Active comparator | Other: Neupro 4 mg / 24 Hr. Transdermal PatchNeupro 4 mg / 24 Hr. Transdermal Patch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing and capable of giving informed consent;
- Between the ages of 18 and 45 years old, inclusive;
- Healthy, per investigator's judgment, based on detailed medical history, clinical laboratory safety tests, vital signs, full physical examination, and ECG;
- Nonsmoker defined as not having smoked or used any form of tobacco within 6 months before screening;
- BMI between 18.5 and 30 kg/m2, inclusive, and body weight ≥50 kg at screening;
Key exclusion criteria (24 listed)
- History of symptomatic orthostatic hypotension with a decrease of ≥20 mmHg in systolic blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when changing from a supine to a 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 screening and Baseline;
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders, and/or drug hypersensitivity;
- History of epilepsy, seizures as an adult, lifetime history of stroke, or transient ischemic attack (TIA) within 1 year prior to screening and Baseline;
- History of sleep attacks or narcolepsy;
- Known or suspected malignancy within 5 years with the exception of treated and cured basal cell carcinoma (skin), squamous cell carcinoma (skin), or in-situ cervical carcinoma;
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 |
|---|---|---|
| LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection) | Drug | LY03003 |
| Neupro 4 mg / 24 Hr. Transdermal PatchNeupro 4 mg /24 Hr. Transdermal Patch | Other | Neupro 4Mg/24Hr Transdermal Patch |
Primary outcome
Cmax
Time frame: 34 days
1 secondary outcome
Adverse Events
Time frame: 34 days
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 14 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Ahad Sabet, MD principal investigator
Pharmaceutical Research Associates
1 site 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 (rotigotine extended release microspheres for intramuscular [IM] injection) and Neupro 4 mg / 24 Hr. Transdermal Patch in people with Parkinson Disease, run by Luye Pharma Group Ltd. at 1 site 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 8 inclusion and 24 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: 34 days). 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 14 Oct 2020.