Pharmacokinetics of Leritrelvir(Ray1216) in Elder Participants

NCT ID: NCT06169085

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2023-10-11

Brief Summary

The purpose of this study is to assess the safety, tolerability and PK of Leritrelvir in elder participants

Conditions

Elder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

young participates

16 young participants(between 18\~45 years old) will be given Leritrelvir. D1：400mg QD D3-D5:400mg TID D6:400mg QD

Group Type: EXPERIMENTAL

Leritrelvir

Intervention Type: DRUG

Oral

Elder participates

16 elder participants(Age≥65 years old) will be given Leritrelvir. 16 young participants(between 18\~45 years old) will be given Leritrelvir. D1：400mg QD D3-D5:400mg TID D6:400mg QD

Group Type: EXPERIMENTAL

Leritrelvir

Intervention Type: DRUG

Oral

Interventions

Leritrelvir

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.

3. Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI<28 kg/m2,BMI is determined by the following equation: BMI = weight/height2 (kg/m2).

4. Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃

Young Participants Only:

5. Participant must be ≥18 to ≤45 years old

Elder Participants Only:

6. Participant must be ≥65 years old

Exclusion Criteria

1. Participants with an allergic disposition (multiple drug and food allergies)

2. Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.

3. Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection),within 2 weeks before screening;

4. Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles

Young Participants Only:

5. Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;

6. Physical examination, vital signs, laboratory tests (blood routine+CRP, urine routine + urine sediment, blood biochemistry, coagulation function, infectious disease test, glycosylated hemoglobin test), 12-lead electrocardiogram, chest CT, abdominal color Doppler ultrasound and other examinations have clinical significance

Elder Participants Only:

7. Participants had a history of or evidence of cardiovascular disease before screening，including uncontrolled hypertension, orthostatic hypotension, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months before screening, or history of tachycardia/bradycardia requiring medical treatment, and degree II-III atrioventricular block.

8. Participants who had other serious organ-systemic serious diseases at screening, including but not limited to respiratory, neurologic, hematologic, endocrine, oncologic, immunologic, psychiatric, or cardiocerebrovascular diseases, and was judged by the investigator to be ineligible for participation in the trial

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuhan Jinyintan Hospital

Wuhan, , China

Countries

China

Other Identifiers

RAY1216-23-04

Identifier Type: -

Identifier Source: org_study_id