Tardive DyskinesiaPhase 1NCT06216054
Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects
A Phase 1 study testing LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant in people with Tardive Dyskinesia and Huntington Disease, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tardive Dyskinesia, Huntington Disease
- What is being tested?
- LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2023to 29 Jul 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 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, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 Sustained-release Tablets in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.
- Conditions
- Tardive Dyskinesia, Huntington Disease
- Being tested
- LPM3770164 sustained release tablet, LPM3770164 sustained release tablet simulant
- Medical subject headings
- Tardive Dyskinesia, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPM3770164 sustained release tabletDrug
administrated orally
LPM3770164 sustained release tablet simulantDrug
administrated orally
| Study group | Role | What they receive |
|---|---|---|
| LPM3770164 | Experimental | LPM3770164 sustained-release tablets will be administrated with multiple doses from 5mg to 30mg on day 1~10 Receives: Drug: LPM3770164 sustained release tablet |
| Placebo | Placebo comparator | LPM3770164 sustained release tablet simulant will be administrated on day 1~10 Receives: Drug: LPM3770164 sustained release tablet simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse event
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Measured: from baseline to day 37
Secondary outcomes (7)
Peak Plasma Concentration (Cmax)
Measured: from day 1 to day 24
Area Under the Curve from time 0 to 24 hours (AUC0-24)
Measured: from day 1 to day 24
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Measured: from day 1 to day 24
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: from day 1 to day 24
Time to maximum concentration (Tmax)
Measured: from day 1 to day 24
Half-life (t1/2)
Measured: from day 1 to day 24
ECG QTc Interval
Measured: from baseline to day 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start19 Dec 2023
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huafang Li, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216054
- Sponsor's protocol ID
- LY03015/CT-CHN-102
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 Sustained-release Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06216054
- Acronym / sponsor ID
- LY03015/CT-CHN-102
- Conditions
- Tardive Dyskinesia, Huntington Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 22 Jan 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 single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPM3770164 | Experimental | Drug: LPM3770164 sustained release tabletLPM3770164 sustained-release tablets will be administrated with multiple doses from 5mg to 30mg on day 1~10 |
| Placebo | Placebo comparator | Drug: LPM3770164 sustained release tablet simulantLPM3770164 sustained release tablet simulant will be administrated on day 1~10 |
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 tabletadministrated orally | Drug | LPM3770164 |
| LPM3770164 sustained release tablet simulantadministrated orally | Drug | Placebo |
Primary outcome
Treatment-emergent adverse event
Time frame: from baseline to day 37
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
7 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 to 24 hours (AUC0-24)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: from day 1 to day 24
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: from day 1 to day 24
Time to maximum concentration (Tmax)
Time frame: from day 1 to day 24
Half-life (t1/2)
Time frame: from day 1 to day 24
ECG QTc Interval
Time frame: from baseline to day 37
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.
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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.
Huafang 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 and LPM3770164 sustained release tablet simulant in people with Tardive Dyskinesia and Huntington Disease, 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. Some participants in this study may receive a placebo. 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?
Treatment-emergent adverse event (time frame: from baseline to day 37). 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.