NCT06474650CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Luye Pharma Group Ltd.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •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
Arms & Interventions
Fed condition
Experimental
Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition
Intervention: LPM3770164 sustained release tablet (Drug)
Fasted condition
Experimental
Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition
Intervention: LPM3770164 sustained release tablet (Drug)
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
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
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)
Time Frame: Predose and up to 240 hours postdose
Secondary Outcomes
- Time to maximum concentration (Tmax)(Predose and up to 240 hours postdose)
- Treatment-emergent adverse event(from baseline to day 25)
- Half-life (t1/2)(Predose and up to 240 hours postdose)
Investigators
Study Sites (1)
Loading locations...
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