ElderPhase 1NCT06169085
Pharmacokinetics of Leritrelvir(Ray1216) in Elder Participants
A Phase 1 study testing Leritrelvir in people with Elder, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to assess the safety, tolerability and PK of Leritrelvir in elder participants Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elder
- What is being tested?
- Leritrelvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2023to 11 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Elder
- Being tested
- Leritrelvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeritrelvirDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Leritrelvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
The Cmax of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
Measured: 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.
Measured: 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.
Measured: Day1~Day8
Secondary outcomes (1)
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Measured: Day1~Day13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start24 Aug 2023
- Primary completion20 Sep 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169085
- Sponsor's protocol ID
- RAY1216-23-04
- Status last verified
- Apr 2024
- First submitted
- 27 Nov 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate Pharmacokinetics, Safety and Tolerability of RAY1216 in Elder Participants
- ClinicalTrials.gov ID
- NCT06169085
- Acronym / sponsor ID
- RAY1216-23-04
- Conditions
- Elder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, tolerability and PK of Leritrelvir in elder participants
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young participates | Experimental | Drug: Leritrelvir16 young participants(between 18~45 years old) will be given Leritrelvir. D1：400mg QD D3-D5:400mg TID D6:400mg QD |
| Elder participates | Experimental | Drug: Leritrelvir16 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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℃
- Participant must be ≥18 to ≤45 years old
Key exclusion criteria (10 listed)
- 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
- Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeritrelvirOral | Drug | Elder participates, young participates |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Day1~Day8
The Cmax of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day1~Day8
The AUCinf of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
Time frame: Day1~Day8
The AUClast of a single dose of Leritrelvir in elder participants and young participates will be evaluated and compared.
1 secondary outcome
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time frame: Day1~Day13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leritrelvir in people with Elder, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Day1~Day8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.