Huntington DiseasePhase 1NCT06474650
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets
A Phase 1 study testing LPM3770164 sustained release tablet in people with Huntington Disease and Tardive Dyskinesia, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease, Tardive Dyskinesia
- What is being tested?
- LPM3770164 sustained release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 25 Sep 2024
- 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
- Subject who voluntarily participate and sign the informed consent form;
- Healthy male/female volunteers aged 18 to 45 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 26.0 kg/m2, inclusive;
- Able to comply with the lifestyle restrictions.
Who cannot join
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
- Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
- Subject has a history of self-mutilation; or at risk of suicide;
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
- Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
Show all 19Show fewer
- Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
- Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
- Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
- Subject has a history of substance abuse within 1 year or a positive urine drug screen;
- Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
- Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia
- Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
- Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
- Subject who has participated in other clinical trials and were enrolled/randomized within 3 months before administration;
- Subject has used blood products or being blood donor or blood loss within 3 months;
- Pregnant, lactating women, or positive pregnancy test;
- Subject who refusal to contraception, or plan to donate sperm or ovums;
- Other conditions which would make participation in the study unsuitable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Two-period, Double-crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets in Healthy Subjects
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.
- Conditions
- Huntington Disease, Tardive Dyskinesia
- Being tested
- LPM3770164 sustained release tablet
- Medical subject headings
- Huntington Disease, Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPM3770164 sustained release tabletDrug
Also called LY03015
Single-dose of 30 mg of LPM3770164 sustained release tablet
| Study group | Role | What they receive |
|---|---|---|
| Fed condition | Experimental | Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition Receives: Drug: LPM3770164 sustained release tablet |
| Fasted condition | Experimental | Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition Receives: Drug: LPM3770164 sustained release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Measured: Predose and up to 240 hours postdose
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Measured: Predose and up to 240 hours postdose
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Predose and up to 240 hours postdose
Secondary outcomes (3)
Treatment-emergent adverse event
Measured: from baseline to day 25
Time to maximum concentration (Tmax)
Measured: Predose and up to 240 hours postdose
Half-life (t1/2)
Measured: Predose and up to 240 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start31 Jul 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hufang Li, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474650
- Sponsor's protocol ID
- LY03015/CT-CHN-103
- Status last verified
- Dec 2024
- First submitted
- 20 Jun 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-period, Double-crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06474650
- Acronym / sponsor ID
- LY03015/CT-CHN-103
- Conditions
- Huntington Disease, Tardive Dyskinesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 25 Jun 2024 (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 A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed condition | Experimental | Drug: LPM3770164 sustained release tabletPeriod in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition |
| Fasted condition | Experimental | Drug: LPM3770164 sustained release tabletPeriod in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject who voluntarily participate and sign the informed consent form;
- Healthy male/female volunteers aged 18 to 45 years;
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 26.0 kg/m2, inclusive;
- Able to comply with the lifestyle restrictions.
Key exclusion criteria (19 listed)
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
- Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
- Subject has a history of self-mutilation; or at risk of suicide;
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
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 |
|---|---|---|
| LPM3770164 sustained release tabletAlso: LY03015Single-dose of 30 mg of LPM3770164 sustained release tablet | Drug | Fasted condition, Fed condition |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Predose and up to 240 hours postdose
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: Predose and up to 240 hours postdose
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Predose and up to 240 hours postdose
3 secondary outcomes
Treatment-emergent adverse event
Time frame: from baseline to day 25
Time to maximum concentration (Tmax)
Time frame: Predose and up to 240 hours postdose
Half-life (t1/2)
Time frame: Predose and up to 240 hours postdose
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 12 Dec 2024.
- 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.
Hufang Li, Doctor principal investigator
Shanghai Mental Health Center
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 LPM3770164 sustained release tablet in people with Huntington Disease and Tardive Dyskinesia, run by Luye Pharma Group Ltd. at 1 site in China.
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 4 inclusion and 19 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 12 Dec 2024. 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 China. 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?
Peak Plasma Concentration (Cmax) (time frame: Predose and up to 240 hours postdose). 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 12 Dec 2024.