Effect of Food and Age on the Pharmacokinetics of LY03017

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuye Pharma Group Ltd.

About this trial

This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers.

Eligibility criteria

Qualifiers

Subject who voluntarily participate and sign the informed consent form.

Part A:Age ≥18 and ≤ 45 years, male and female.

Part B:Age ≥65 years, male and female.

Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.

Disqualifiers

Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.

Part A:Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.

Part B:Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders. Subjects with well-controlled, chronic and stable medical conditions (e.g., hypertension, type 2 diabetes, hyperlipidaemia) which are not expected to compromise subject safety or interfere with the study results will not be excluded.

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.

Trial design

Treatments tested in this trial

  • LY03017
  • LY03017

Treatment groups

26 Participants
are divided into 3 treatment groups

Sponsors and collaborators