NCT07292233
Active, not recruiting
Phase 1
A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects
InterventionsLY03020
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Luye Pharma Group Ltd.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Maximum observed concentration (Cmax) of LPM787000048 in plasma
Overview
Brief Summary
This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 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
- •Subjects sign informed consent voluntarily.
- •Male or female aged 18 to 45 years.
- •Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.
Exclusion Criteria
- •Subjects have any clinically significant medical condition or chronic disease.
- •Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
- •Subjects with a history of orthostatic hypotension or syncope.
- •Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
- •Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
- •Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
- •Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.
- •Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation.
- •Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.
Arms & Interventions
fasted,fed
Experimental
Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively.
Intervention: LY03020 (Drug)
fed,fasted
Experimental
Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively.
Intervention: LY03020 (Drug)
Outcomes
Primary Outcomes
Maximum observed concentration (Cmax) of LPM787000048 in plasma
Time Frame: up to Day 12
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
Time Frame: up to Day 12
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma
Time Frame: up to Day 12
Secondary Outcomes
- Time to maximum observed concentration (Tmax) of LPM787000048 in plasma(up to Day 12)
- Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma(up to Day 12)
- Number of participants with adverse events (AEs).(up to Day 12)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Once-A-Day Pregabalin For Partial SeizuresCTRI/2011/08/001976Pfizer Limited264
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety and efficacy of daily 200 mg fluvoxamine as add-on therapy to standard of care in moderate severity COVID-19 patientsSARS-CoV-2 infected patientsMedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2020-002299-11-HUSigmaDrugs Research Ltd.100
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel group, multicenter twoweek study to evaluate the efficacy and safety of once-daily, intranasaladministration of GW685698X aqueous nasal spray 100 mcg in adult andadolescent subjects with seasonal allergic rhinitis in EuropeSeasonal allergic rhinitis (SAR)EUCTR2004-004434-14-SEGlaxoSmithKline Research & Development Ltd288
Active, not recruiting
Phase 1
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients with Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and are Treated with Insulin (ODYSSEY DM - Insulin)EUCTR2015-000799-92-ITSANOFI-AVENTIS GROUPE517
Active, not recruiting
Not Applicable
Evaluation of cardiovascular outcomes in patients with type 2 diabetes after acute coronary syndrome during treatment with AVE0010 (lixisenatide)EUCTR2009-012852-26-LVsanofi-aventis Recherche & Développement6,000