Pharmacokinetics of Leritrelvir(Ray1216) in Elder Participants

NCT06169085 | Completed Phase 1

• 1 other identifier: RAY1216-23-04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of participants with drug-related adverse events as assessed by CTCAE v5.0

  Day1~Day13

Study Arms (2)

young participates

EXPERIMENTAL

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

Drug: Leritrelvir

Elder participates

EXPERIMENTAL

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

Interventions

Leritrelvir DRUG

Oral

Elder participates; young participates

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• 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).
• Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃
• Young Participants Only:
• Participant must be ≥18 to ≤45 years old
• Elder Participants Only:
• Participant must be ≥65 years old

You may not qualify if:

• Participants with an allergic disposition (multiple drug and food allergies)
• Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
• Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection),within 2 weeks before screening;
• Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles
• Young Participants Only:
• Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;
• 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:
• 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.
• 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

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Wuhan Jinyintan Hospital

Wuhan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 13, 2023
• Study Start: August 24, 2023
• Primary Completion: September 20, 2023
• Study Completion: October 11, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)