Renal ImpairmentPhase 1NCT05731804

Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir

A Phase 1 study testing SIM0417 600 mg; Ritonavir100 mg, SIM0417 375 mg; Ritonavir100 mg and SIM0417 750 mg; Ritonavir100 mg in people with Renal Impairment and Hepatic Impairment, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment, Hepatic Impairment
What is being tested?: SIM0417 600 mg; Ritonavir100 mg, SIM0417 375 mg; Ritonavir100 mg and SIM0417 750 mg; Ritonavir100 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteChina
Study dates: 1 Mar 2023to 31 Dec 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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

● PartA:
All subjects
Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
Male and female subjects aged ≥18 years and ≤75 years old.
Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 18 and ≤ 28 kg/m^2.
The results of screening and baseline blood pregnancy examination of women of childbearing potential are negative, and they are willing to take effective contraceptive measures during the trial and within 3 months after the last administration of the investigational product, or have postmenopause or surgical sterilization; male subjects have no fertility plan during the trial and within 3 months after the last administration of the investigational product and voluntarily take effective contraceptive measures or have surgical sterilization.

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Subjects with renal impairment
Glomerular filtration rate should meet the following criteria ( eGFR = eGFR（CKD-EPI）× BSA / 1.73): Mild renal impairment ( CKD2 ) 60-89 mL/min (both values included; Moderate renal impairment ( CKD3 ) 30-59 mL/min (both values included).
The renal function status is stable, and the GFR results of the two tests before administration (at least 3 days interval ) must be in the same CKD stage.
No medication within 14 days before enrollment, or with a stable medication regimen for the treatment of renal impairment or other comorbidities (the type, dose or frequency of medication has not been adjusted for at least 2 weeks).
Total bilirubin, ALT and AST ≤ 2 ×ULN.
Be in acceptable physical condition except for renal impairment and complications, according to medical history inquiry, physical examination, vital signs, laboratory tests (Hematology, blood biochemistry, urinalysis, coagulation function, thyroid function ), 12-lead ECG, chest radiograph, thyroid ultrasound, abdominal ultrasound(judged by the investigator).
Subjects with normal renal function
Age-matched (±10 years), weight-matched (±15kg), and gender-matched with subjects in the renal impairment group.
Glomerular filtration rate( eGFR = eGFR（CKD-EPI）× BSA / 1.73)≥ 90 mL / min.
Vital signs, physical examination, laboratory tests (Hematology, blood biochemistry, urinalysis, coagulation function, thyroid function ), 12 lead ECG, chest radiograph, abdominal ultrasound, thyroid ultrasound examination are normal or abnormal with no clinical significance.
● PartB
All subjects
Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
Male and female subjects aged ≥18 years and ≤75 years old.
Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 18 and ≤ 28 kg/m^2.
The results of screening and baseline blood pregnancy examination of women of childbearing potential are negative, and they are willing to take effective contraceptive measures during the trial and within 3 months after the last administration of the investigational product, or have postmenopause or surgical sterilization; male subjects have no fertility plan during the trial and within 3 months after the last administration of the investigational product and voluntarily take effective contraceptive measures or have surgical sterilization.
Subjects with hepatic impairment
With chronic ( diagnosis ≥ 6 months, stable disease ≥ 4 weeks ) moderate liver dysfunction ( Child-Pugh score: 7-9 points ) caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis or other causes ( except drug-induced liver injury ). If it is impossible to judge whether the disease is stable or not, 2 examinations must be carried out during the screening period with an interval of at least 2 weeks to judge the stable disease state. The investigators diagnosed chronic liver function damage according to standard diagnosis and treatment methods, combined with the subject's previous medical history, laboratory tests, liver biopsy or imaging examination and other documents, and then evaluated according to Child-Pugh classification (according to encephalopathy grade, ascites, serum albumin, serum bilirubin, prothrombin time prolongation in seconds).
No medication within 14 days before enrollment, or with a stable medication regimen for the treatment of hepatic impairment or other comorbidities (the type, dose or frequency of medication has not been adjusted for at least 2 weeks).
Glomerular filtration rate ( absolute eGFR = eGFR（CKD-EPI） × BSA / 1.73 ) ≥60 mL / min.
Be in acceptable physical condition except for hepatic impairment and complications, according to medical history inquiry, physical examination, vital signs, laboratory tests (Hematology, blood biochemistry, urinalysis, coagulation function, thyroid function ), 12-lead ECG, chest radiograph, thyroid ultrasound, abdominal ultrasound(judged by the investigator).
Subjects with normal hepatic function
Age-matched (±10 years), weight-matched (±15kg), and gender-matched with subjects in the hepatic impairment group.
Total bilirubin, ALT and AST ≤ the upper limit of normal.
Vital signs, physical examination, laboratory examination (Hematology, blood biochemistry, urinalysis, coagulation function, thyroid function ), 12-lead ECG, chest radiograph, abdominal ultrasound, thyroid ultrasound examination are normal or abnormal with no clinical significance.

Who cannot join

● PartA:
All subjects
Breastfeeding women.
Those with allergies, including a history of severe drug allergy or drug allergy; or may be allergic to the study drug or any excipients of the study drug.
Difficulties in venous blood collection.
With severe infection, trauma, major surgical operation, digestive system surgery, and affecting drug absorption within 4 weeks before screening.

Show all 64Show fewer

Within six months before screening, patients with myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure ( NYHA II-IV ), or history of supraventricular or ventricular arrhythmia or left ventricular impairment which was Clinically significant and requiring treatment or intervention.
Participated in clinical trials of any drug intervention within 3 months before screening.
Blood donation ≥ 400 mL within 3 months before screening, or received blood transfusion or blood products within 1 month before the screening.
Those who are addicted to smoking or drinking within 3 months before screening, and who cannot stop smoking and drinking during the test, or those who have a positive breath test for alcohol. (Remarks: addicted to Smoking is defined as ≥5 cigarettes/day; alcoholism is defined as daily drinking exceeding the following standard amounts: 570 mL of beer, 750 mL of light beer, 200 mL of red wine or 60 mL of white wine, each containing about 20 g of alcohol ).
With Drug abuse history or a positive drug abuse screen.
Used any CYP3A4 potent inducer within 28 days before the first administration.
Special diets ( including pitayas, mangoes, grapefruit, caffeine-containing foods or drinks, etc. ) or intense exercise were taken within 48 hours before the first administration of the study drug.
Those who have been vaccinated within 1 month before screening (except for the COVID-19 vaccine), or who plan to be vaccinated during treatment / within 2 weeks after the last dose of study drug.
12-lead ECG at screening, QT interval (QTcF) corrected by Fridericia formula ≥ 470 msec (female)/450 msec (male).
Be positive in SARS-CoV-2 nucleic acid test or SARS-CoV-2 antigen at screening.
The investigator judges that there are other factors of subjects that are not suitable for participating in this trial.
Subjects with renal impairment
Renal transplantation.
Requires renal dialysis during the study.
Urinary incontinence or anuria.
In addition to the disease itself causing the diagnosis of renal impairment, subjects suffering from acute diseases of any other organs, and suffering any chronic diseases that may affect the in vivo process of the study drug (e.g.hepatic impairment, etc.)are inappropriate for participation in this trial(judged by the investigator).
Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5×ULN), or significant clinically significant bleeding symptoms or definite hemorrhagic tendency within 3 months before screening, such as alimentary tract hemorrhage, gastric ulcer bleeding, etc., or are receiving thrombolytic anticoagulation therapy.
At screening, systolic pressure >160 mmHg, diastolic pressure >100 mmHg; pulse >100 bpm.
Combined virus infection ( anti-HCV positive, anti-HIV positive, HBsAg positive ) or syphilis infection.
Subjects with normal renal function
WIth a history of cardiovascular, liver, kidney, digestive tract, immune, blood, endocrine, metabolism, cancer, mental and neurological diseases at the time of screening.
At screening, systolic pressure <90 mmHg or >140 mmHg, diastolic pressure <60 mmHg or >90 mmHg; pulse <55 bpm or >100 bpm.
Combined virus infection ( anti-HCV positive, anti-HIV positive, HBsAg positive ) or syphilis infection.
Prescription, non-prescription and traditional Chinese medicine ( Chinese herbal medicine, Chinese patent medicine ) were used within 2 weeks before screening.
● PartB:
All subjects
Breastfeeding women.
Those with allergies, including a history of severe drug allergy or drug allergy; or may be allergic to the study drug or any excipients of the study drug.
Difficulties in venous blood collection.
With severe infection, trauma, major surgical operation, digestive system surgery, and affecting drug absorption within 4 weeks before screening.
With six months before screening, patients with myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure ( NYHA II-IV ), or intervention of supraventricular or ventricular arrhythmia or left ventricular dysfunction, have clinical significance and require treatment.
Participated in clinical trials of any drug intervention within 3 months before screening.
Blood donation ≥ 400 mL within the first 3 months before screening, or received blood transfusion or blood products within 1 month before the screening.
With addicted to smoking and drinking within 3 months before screening, cannot smoke or drink alcohol during the study period, or have a positive alcohol breath test. (Remarks: Smoking is defined as ≥5 cigarettes/day; alcoholism is defined as daily drinking exceeding the following standard amounts: 570 mL of beer, 750 mL of light beer, 200 mL of red wine or 60 mL of white wine, each containing about 20 g of alcohol ).
With Drug abuse history or a positive drug abuse screen.
Used any CYP3A4 potent inducer within 28 days before the first administration.
Special diets ( including pitayas, mangoes, grapefruit, caffeine-containing foods or drinks, etc. ) or intense exercise were taken within 48 hours before the first administration of the study drug.
Vaccines ( other than new coronavirus vaccines ) have been vaccinated within 1 month before screening or plan to be vaccinated during treatment or within 2 weeks after the last administration of the study drug.
13.12-lead ECG at screening, QT interval (QTcF) corrected by Fridericia formula ≥ 470 msec (female)/450 msec (male).
14. Be positive in SARS-CoV-2 nucleic acid test or SARS-CoV-2 antigen at screening.
15. Other factors of subjects that are not suitable for participating in this trial(judged by the investigator).
Subjects with hepatic impairment
Have ever received a liver transplant.
With liver failure or with severe complications of cirrhosis.
Patients with hepatic encephalopathy ( grade 3-4 hepatic encephalopathy according to Child-Pugh score ).
Fluctuating or rapidly worsening liver function, manifested by extensive changes or deterioration of clinical symptoms and/or laboratory tests of liver damage symptoms during screening ( such as advanced ascites, fever, and active gastrointestinal bleeding ).
Severe portal hypertension, or transjugular intrahepatic portosystemic shunt, or esophageal variceal bleeding in the past 2 months.
Suspected or diagnosed with liver cancer or other malignant tumors.
Received drugs with clear potential hepatotoxicity (such as halothane, etc.) within 3 months before administration of study.
In addition to the disease itself causing the diagnosis of hepatic impairment, subjects suffering from acute diseases of any other organs, and any chronic diseases that may affect the in vivo process of the study drug (e.g.renal impairment, etc.) are inappropriate for participation in this trial(judged by the investigator).
Anticoagulant therapy with warfarin or related coumarins.
At screening, systolic pressure >160 mmHg, diastolic pressure >100 mmHg; pulse >100 bpm.
Combined virus infection ( anti-HIV positive ) or syphilis infection.
Subjects with normal hepatic function
WIth a history of cardiovascular, liver, kidney, digestive tract, immune, blood, endocrine, metabolism, cancer, mental and neurological diseases at the time of screening.
At screening, systolic pressure <90 mmHg or >140 mmHg, diastolic pressure <60 mmHg or >90 mmHg; pulse <55 bpm or >100 bpm.
Combined virus infection ( anti-HCV positive, anti-HIV positive, HBsAg positive ) or syphilis infection.
Prescription, non-prescription and traditional Chinese medicine ( Chinese herbal medicine, Chinese patent medicine ) were used within 2 weeks before screening.

Trial locations and contacts

1 site in 1 country.

Juan Wu contact

+86 18920299268

wujuan3@simcere.com

Danny Chen contact

China1 site

Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Wei Zhao, Doctor, +86 15131190710, zhao4wei2@hotmail.com

Other trials in China

About this study

Official title: A Multicenter, Non-randomized, Open-label, Parallel Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417/Ritonavir After a Single Dose in Subjects With Renal or Hepatic Impairment

This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).

Read the detailed description

This is a multicenter, non-randomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function.

Part A includes 4 cohorts, each of which plans to enroll 6-12 subjects, for a total of 24-48 subjects. Participants will be allocated into normal renal function or mild/moderate renal impairment groups based on their estimated glomerular filtration rate.

Part B includes 2 cohorts, each of which plans to enroll 6-12 subjects, for a total of 12-24 subjects. Participants will be allocated into normal hepatic function or moderate hepatic impairment groups based on their Child-Pugh score.

Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.

Conditions: Renal Impairment, Hepatic Impairment
Being tested: SIM0417 600 mg; Ritonavir100 mg, SIM0417 375 mg; Ritonavir100 mg, SIM0417 750 mg; Ritonavir100 mg
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SIM0417 600 mg; Ritonavir100 mgDrug
SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.
SIM0417 375 mg; Ritonavir100 mgDrug
SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.
SIM0417 750 mg; Ritonavir100 mgDrug
SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.

Study groups in NCT05731804
Study group	Role	What they receive
Cohort 1 of Part A	Experimental	Subjects with mild renal impairment(SIM0417 600 mg; Ritonavir100 mg ) Receives: Drug: SIM0417 600 mg; Ritonavir100 mg
Cohort 2 of Part A	Experimental	Subjects with moderate renal impairment(SIM0417 375 mg; Ritonavir100 mg ) Receives: Drug: SIM0417 375 mg; Ritonavir100 mg
Cohort 3 of Part A	Experimental	Subjects with normal renal function(SIM0417 600 mg; Ritonavir100 mg ) Receives: Drug: SIM0417 600 mg; Ritonavir100 mg
Cohort 4 of Part A	Experimental	Subjects with normal renal function(SIM0417 375 mg; Ritonavir100 mg ) Receives: Drug: SIM0417 375 mg; Ritonavir100 mg
Cohort 5 of Part B	Experimental	Subjects with moderate hepatic impairment (SIM0417 750 mg; Ritonavir100 mg ) Receives: Drug: SIM0417 750 mg; Ritonavir100 mg
Cohort 6 of Part B	Experimental	Subjects with normal hepatic function(SIM0417 750 mg; Ritonavir100 mg ) Receives: Drug: SIM0417 750 mg; Ritonavir100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of SIM0417 in Part A
Cmax of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
AUC0-t of SIM0417 in Part A
AUC0-t of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
AUC0-∞ of SIM0417 in Part A
AUC0-∞ of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
Cmax of SIM0417 in Part B
Cmax of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
AUC0-t of SIM0417 in Part B
AUC0-t of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
AUC0-∞ of SIM0417 in Part B
AUC0-∞ of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration

Secondary outcomes (19)

Tmax of SIM0417 in Part A
Tmax of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
t1/2 of SIM0417 in Part A
t1/2 of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
CL/F of SIM0417 in Part A
CL/F of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
Vz/F of SIM0417 in Part A
Vz/F of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
Ae of SIM0417 in Part A
Ae of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 96 hours from SIM0417 administration
protein binding of SIM0417 in Part A
Plasma protein binding rate of SIM0417 in Part A when SIM0417 combined with ritonavir
Measured: Up to 12 hours from SIM0417 administration
Vital Signs in Part A
Number of Participants With Clinically Notable Vital Signs in Part A
Measured: Up to 5 days from the start of administration
ECG in Part A
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values in Part A
Measured: Up to 5 days from the start of administration
Laboratory Tests in Part A
Number of Participants With Clinically Notable Laboratory Tests in Part A
Measured: Up to 5 days from the start of administration
Adverse Events in Part A
Number of Participants With Adverse Events in Part A
Measured: Up to 14 days from the start of administration
Tmax of SIM0417 in Part B
Tmax of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
t1/2 of SIM0417 in Part B
t1/2 of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
CL/F of SIM0417 in Part B
CL/F of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
Vz/F of SIM0417 in Part B
Vz/F of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 48 hours from SIM0417 administration
Protein binding of SIM0417 in Part B
Plasma protein binding rate of SIM0417 in Part B when SIM0417 combined with ritonavir
Measured: Up to 12 hours from SIM0417 administration
Vital Signs in Part B
Number of Participants With Clinically Notable Vital Signs in Part B
Measured: Up to 5 days from the start of administration
ECG in Part B
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values in Part B
Measured: Up to 5 days from the start of administration
Laboratory Tests in Part B
Number of Participants With Clinically Notable Laboratory Tests in Part B
Measured: Up to 5 days from the start of administration
Adverse Events in Part B
Number of Participants With Adverse Events in Part B
Measured: Up to 14 days from the start of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202331 Dec 2023

First posted16 Feb 2023
Study start1 Mar 2023 (estimated)
Primary completion1 Dec 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05731804
Sponsor's protocol ID: SIM0417-105
Status last verified: Mar 2023
First submitted: 18 Jan 2023
Last updated: 8 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Juan Wu

+86 18920299268

wujuan3@simcere.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Non-randomized, Open-label, Parallel Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417/Ritonavir After a Single Dose in Subjects With Renal or Hepatic Impairment
ClinicalTrials.gov ID: NCT05731804
Acronym / sponsor ID: SIM0417-105
Conditions: Renal Impairment, Hepatic Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 72 participants (estimated)
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Mar 2023 (estimated)
Primary completion: 1 Dec 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 16 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1 of Part A	Experimental	Drug: SIM0417 600 mg; Ritonavir100 mgSubjects with mild renal impairment(SIM0417 600 mg; Ritonavir100 mg )
Cohort 2 of Part A	Experimental	Drug: SIM0417 375 mg; Ritonavir100 mgSubjects with moderate renal impairment(SIM0417 375 mg; Ritonavir100 mg )
Cohort 3 of Part A	Experimental	Drug: SIM0417 600 mg; Ritonavir100 mgSubjects with normal renal function(SIM0417 600 mg; Ritonavir100 mg )
Cohort 4 of Part A	Experimental	Drug: SIM0417 375 mg; Ritonavir100 mgSubjects with normal renal function(SIM0417 375 mg; Ritonavir100 mg )
Cohort 5 of Part B	Experimental	Drug: SIM0417 750 mg; Ritonavir100 mgSubjects with moderate hepatic impairment (SIM0417 750 mg; Ritonavir100 mg )
Cohort 6 of Part B	Experimental	Drug: SIM0417 750 mg; Ritonavir100 mgSubjects with normal hepatic function(SIM0417 750 mg; Ritonavir100 mg )

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

● PartA:
● PartB

Key exclusion criteria (64 listed)

● PartA:
● PartB:
13.12-lead ECG at screening, QT interval (QTcF) corrected by Fridericia formula ≥ 470 msec (female)/450 msec (male).
14. Be positive in SARS-CoV-2 nucleic acid test or SARS-CoV-2 antigen at screening.
15. Other factors of subjects that are not suitable for participating in this trial(judged by the investigator).

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
SIM0417 600 mg; Ritonavir100 mgSIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.	Drug	Cohort 1 of Part A, Cohort 3 of Part A
SIM0417 375 mg; Ritonavir100 mgSIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.	Drug	Cohort 2 of Part A, Cohort 4 of Part A
SIM0417 750 mg; Ritonavir100 mgSIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.	Drug	Cohort 5 of Part B, Cohort 6 of Part B

Primary outcome

Cmax of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
Cmax of SIM0417 in Part A when SIM0417 combined with ritonavir
AUC0-t of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
AUC0-t of SIM0417 in Part A when SIM0417 combined with ritonavir
AUC0-∞ of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
AUC0-∞ of SIM0417 in Part A when SIM0417 combined with ritonavir
Cmax of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
Cmax of SIM0417 in Part B when SIM0417 combined with ritonavir
AUC0-t of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
AUC0-t of SIM0417 in Part B when SIM0417 combined with ritonavir
AUC0-∞ of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
AUC0-∞ of SIM0417 in Part B when SIM0417 combined with ritonavir

19 secondary outcomes

Tmax of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
t1/2 of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
CL/F of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
Vz/F of SIM0417 in Part A
Time frame: Up to 48 hours from SIM0417 administration
Ae of SIM0417 in Part A
Time frame: Up to 96 hours from SIM0417 administration
protein binding of SIM0417 in Part A
Time frame: Up to 12 hours from SIM0417 administration
Vital Signs in Part A
Time frame: Up to 5 days from the start of administration
ECG in Part A
Time frame: Up to 5 days from the start of administration
Laboratory Tests in Part A
Time frame: Up to 5 days from the start of administration
Adverse Events in Part A
Time frame: Up to 14 days from the start of administration
Tmax of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
t1/2 of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
CL/F of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
Vz/F of SIM0417 in Part B
Time frame: Up to 48 hours from SIM0417 administration
Protein binding of SIM0417 in Part B
Time frame: Up to 12 hours from SIM0417 administration
Vital Signs in Part B
Time frame: Up to 5 days from the start of administration
ECG in Part B
Time frame: Up to 5 days from the start of administration
Laboratory Tests in Part B
Time frame: Up to 5 days from the start of administration
Adverse Events in Part B
Time frame: Up to 14 days from the start of administration

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
Individual participant dataSharing planned: No

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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.

Juan Wu contact

+86 18920299268

wujuan3@simcere.com

Danny Chen contact

Wei Zhao principal investigator

Shandong First Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 31 inclusion and 64 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: status not confirmed, as of the sponsor's last update on 8 Mar 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Juan Wu (+86 18920299268, wujuan3@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of SIM0417 in Part A (time frame: Up to 48 hours from SIM0417 administration). The study lists 6 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 NCT05731804.

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 8 Mar 2023.