Pharmacokinetics of Leritrelvir(Ray1216) in Elder Participants

A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate Pharmacokinetics, Safety and Tolerability of RAY1216 in Elder Participants

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

Study Overview

• Status: Completed
• Conditions: Elder
• Intervention / Treatment: Drug: Leritrelvir

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Wuhan, China
    • Wuhan Jinyintan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: young participates; 16 young participants(between 18~45 years old) will be given Leritrelvir. D1：400mg QD D3-D5:400mg TID D6:400mg QD	Drug: Leritrelvir; Oral
Experimental: 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	Drug: Leritrelvir; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	The Cmax of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.	Day1~Day8
Area under the concentration-time curve from time zero to infinity (AUCinf)	The AUCinf of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.	Day1~Day8
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)	The AUClast of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.	Day1~Day8

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with drug-related adverse events as assessed by CTCAE v5.0	Day1~Day13

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RAY1216-23-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No