A Food Effect Study of LY03020 in Healthy Subjects (NCT07292233) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Food Effect Study of LY03020 in Healthy Subjects
China16 participantsStarted 2025-07-30
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Maximum observed concentration (Cmax) of LPM787000048 in plasma
Timeframe: up to Day 12
2
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
Timeframe: up to Day 12
3
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma