Hepatic ImpairmentPhase 1NCT06161259
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
A Phase 1 study testing Leritrelvir(Ray1216) in people with Hepatic Impairment, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216) Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Leritrelvir(Ray1216)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2023to 7 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent.
- BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2.
- Participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product.
- 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 with hepatic impairment only:
- Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
- Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants
Who cannot join
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- QTcF (male) > 470ms，QTcF (female) > 480ms
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months.
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening
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- Participants with Normal Hepatic Function Only:
- Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
- Participants with Hepatic Impairment Only:
- Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
- Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices
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 the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Leritrelvir(RAY1216)
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)
- Conditions
- Hepatic Impairment
- Being tested
- Leritrelvir(Ray1216)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leritrelvir(Ray1216)Drug
Participants receive Leritrelvir orally.
| Study group | Role | What they receive |
|---|---|---|
| Child-Pugh A | Experimental | 8 participants with mild hepatic impairment (Child-Pugh A) will be given 400mg of Leritrelvir(RAY1216) Receives: Drug: Leritrelvir(Ray1216) |
| Child-Pugh B | Experimental | 8 participants with mild hepatic impairment (Child-Pugh B) will be given 400mg of Leritrelvir(RAY1216) Receives: Drug: Leritrelvir(Ray1216) |
| Normal hepatic function | Experimental | 8 participants with normal hepatic function will be given 400mg of Leritrelvir(RAY1216) Receives: Drug: Leritrelvir(Ray1216) |
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 participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Measured: Day 1 to Day 4
Area under the concentration-time curve from time zero to infinity (AUCinf)
The AUCinf of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Measured: Day 1 to Day 4
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 participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Measured: Day 1 to Day 4
Secondary outcomes (1)
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start14 Sep 2023
- Primary completion1 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies 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
- 24 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
- NCT06161259
- Sponsor's protocol ID
- RAY1216-23-06
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li C, Mai J, Wu M, Zhang H, Li X, Li H, Li Y, Ding Y. Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0137724. doi: 10.1128/aac.01377-24. Epub 2024 Dec 17.
PubMed 39688408
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. 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 the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Leritrelvir(RAY1216)
- ClinicalTrials.gov ID
- NCT06161259
- Acronym / sponsor ID
- RAY1216-23-06
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 7 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.
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child-Pugh A | Experimental | Drug: Leritrelvir(Ray1216)8 participants with mild hepatic impairment (Child-Pugh A) will be given 400mg of Leritrelvir(RAY1216) |
| Child-Pugh B | Experimental | Drug: Leritrelvir(Ray1216)8 participants with mild hepatic impairment (Child-Pugh B) will be given 400mg of Leritrelvir(RAY1216) |
| Normal hepatic function | Experimental | Drug: Leritrelvir(Ray1216)8 participants with normal hepatic function will be given 400mg of Leritrelvir(RAY1216) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent.
- BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2.
- Participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product.
- 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.
- Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
Key exclusion criteria (11 listed)
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- QTcF (male) > 470ms，QTcF (female) > 480ms
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months.
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
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 |
|---|---|---|
| Leritrelvir(Ray1216)Participants receive Leritrelvir orally. | Drug | Child-Pugh A, Child-Pugh B, Normal hepatic function |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 to Day 4
The Cmax of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day 1 to Day 4
The AUCinf of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
Time frame: Day 1 to Day 4
The AUClast of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
1 secondary outcome
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 to Day 7
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 7 Dec 2023.
- Derived from this study: PubMed 39688408Li C, Mai J, Wu M, Zhang H, Li X, Li H, Li Y, Ding Y. Single-dose tolerability and pharmacokinetics of leritrelvir in Chinese patients with hepatic impairment and healthy matched controls. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0137724. doi: 10.1128/aac.01377-24. Epub 2024 Dec 17.
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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(Ray1216) in people with Hepatic Impairment, 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 7 inclusion and 11 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 7 Dec 2023. 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: Day 1 to Day 4). 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?
On the ClinicalTrials.gov record for NCT06161259, which also lists 1 linked publication.
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 7 Dec 2023.