Renal ImpairmentPhase 1NCT05497297
A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment
A Phase 1 study testing HSK7653 tablets in people with Renal Impairment, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- HSK7653 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 26 Oct 2022
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with renal impairment(RI):
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 79 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m^2));
- Subjects with medically stable RI until study completion corresponding to the Classifications of Renal Function based on GFR: mild RI: 60≤GFR<90 mL/min; moderate RI: 30≤GFR<60 mL/min, severe RI:15≤GFR<30 mL/min, kidney failure:GFR<15 mL/min (not on hemodialysis);
- Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests (hematology, serum chemistry, coagulation and urinalysis test) results were deemed appropriate by the investigator;
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- Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities (last more than four weeks in good compliance);
- Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration;
- Subjects with normal renal function :
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 79 years (inclusive), male and female, age and sex must be matched with subjects with RI;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg, weight must be matched with subjects with RI. Body mass index (BMI) : 18-30 kg/m^2 (inclusive) (BMI= weight (kg)/height2 (m^2));
- 90≤GFR<130 mL/min;
- Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests (hematology, serum chemistry, coagulation and urinalysis test) results were deemed appropriate by the investigator;
- Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for comorbidities (last more than four weeks in good compliance);
- Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration；
Who cannot join
- Subjects who have a allergic history of DPP4 inhibitors or have a history of allergy to the test drug and the related compounds;
- Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening；
- History or clinical evidence of acute or chronic pancreatitis, or clinically significant abnormalities in blood lipase and/or blood amylase results at screening;
- Have conditions that may affect drug absorption, distribution, metabolism, or excretion (e.g., disease, drugs or surgery);
- Use of any DPP-IV enzyme inhibitor within 2 weeks prior to the screening;
- Experienced severe hypoglycemia within 3 months before screening;
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- Acute renal failure;
- Smoking more than 5 cigarettes per day within 3 months prior to screening or smoking during the study；
- Average alcohol intake is more than 14 unit per week (1unit=17.7 mL alcohol , 1 unit=357mL 5% alcohol beer, or 43mL 40% alcohol spirit, or 147mL 12% alcohol wine) within the 3 months prior to screening, or taking any alcohol during study or a positive ethanol breath test at screening;
- Drug abuse history within 5 years prior to screening, or positive urine drug screen at screening；
- History of high consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) , consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration ；
- Participation in another clinical trial within 3 months before screening；
- Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening；
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2 × upper limit of normal, or bilirubin > 1.5 × upper limit of normal；
- Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or anti-treponema pallidum specific antibody；
- A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial；
- Not suitable for this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Study to Assess the Pharmacokinetics of HSK7653 Tablets in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function
This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.
Read the detailed description
This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, pharmacodynamics and safety of a single dose of HSK7653 10 mg in subjects with mild, moderate, and severe renal impairment , subjects with kidney failure and the control subjects with normal renal function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 29), and a follow-up call on Day 32.
Subjects will be enrolled in the following groups:
Glomerular filtration rate (GFR, unit mL/min/1.73m^2) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening, Multiply it by BSA, then divide by 1.73 to convert to absolute GFR (unit, mL/min) (group A1) mild renal impairment (60 ≤ GFR< 90 mL/min); (group B1) moderate renal impairment (30 ≤ GFR<60 mL/min); (group C1) severe renal impairment (15 ≤ GFR< 30 mL/min); (group D1) kidney failure (<15 mL/min, not on hemodialysis); (group A2,B2,C2,D2) control subjects with normal renal function will be matched with subjects with renal impairment by weight, age, and sex (GFR≥90 mL/min).If subjects in group A2 can be matched with the subjects in groups A1 and B1 at the same time, the subjects in group B2 will not be enrolled, and so on.
Approximately 64 subjects will be enrolled in total.
- Conditions
- Renal Impairment
- Being tested
- HSK7653 tablets
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK7653 tabletsDrug
Also called HSK7653
HSK7653, tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| Mild Renal Impairment | Experimental | A1 group subjects will receive a single dose of 10 mg HSK7653 Receives: Drug: HSK7653 tablets |
| Moderate Renal Impairment | Experimental | B1 group subjects will receive a single dose of 10 mg HSK7653 Receives: Drug: HSK7653 tablets |
| Severe Renal Impairment | Experimental | C1 group subjects will receive a single dose of 10 mg HSK7653 Receives: Drug: HSK7653 tablets |
| Kidney failure | Experimental | D1 group subjects will receive a single dose of 10 mg HSK7653 Receives: Drug: HSK7653 tablets |
| Normal Renal function | Experimental | A2, B2, C2 and D2 group subjects will receive a single dose of 10 mg HSK7653, If the age, sex and weight of the subjects in group A2 can be matched with the subjects in groups A1 and B1 at the same time, the subjects in group B2 will not be enrolled, and so on. Receives: Drug: HSK7653 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
AUC0-t
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
AUC0-inf
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
Secondary outcomes (11)
Tmax
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
t1/2
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
Vz/F
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
CL/F
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
Ae
The pharmacokinetic parameters of HSK7653 in urine
Measured: Predose and 168 hours after dosing
Fe
The pharmacokinetic parameters of HSK7653 in urine
Measured: Predose and 168 hours after dosing
CLr
The pharmacokinetic parameters of HSK7653 in urine
Measured: Predose and 168 hours after dosing
DPP4 inhibition AUEC
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Predose and 1, 24, 72, 168, 336 hours after dosing
DPP4 inhibition Emax
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Predose and 1, 24, 72, 168, 336 hours after dosing
DPP4 inhibition E336h
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Predose and 1, 24, 72, 168, 336 hours after dosing
The number of volunteers with adverse events as a measure of safety
The number of volunteers with adverse events as a measure of safety
Measured: Day 1 to Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start4 Aug 2022
- Primary completion23 Oct 2022
- Study completion26 Oct 2022
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 Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Meixia, Principal investigator, Beijing Jishuitan HospitalZhang dongliang, Principal investigator, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497297
- Sponsor's protocol ID
- HSK7653-106
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi D, Chen L, Li G, Wu N, Zhang F, Wang X, Mu N, Chen X, Yang X, Lu J, Lu Y, Wang M, Zhang D. Pharmacokinetics, Pharmacodynamics, and Safety of Single Dose HSK7653 Tablets in Chinese Subjects with Normal or Impaired Renal Function. Clin Pharmacokinet. 2024 Feb;63(2):227-239. doi: 10.1007/s40262-023-01333-4. Epub 2024 Jan 6.
PubMed 38184489
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Assess the Pharmacokinetics of HSK7653 Tablets in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT05497297
- Acronym / sponsor ID
- HSK7653-106
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 11 Aug 2022 (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 is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.
Detailed description
This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, pharmacodynamics and safety of a single dose of HSK7653 10 mg in subjects with mild, moderate, and severe renal impairment , subjects with kidney failure and the control subjects with normal renal function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 29), and a follow-up call on Day 32.
Subjects will be enrolled in the following groups:
Glomerular filtration rate (GFR, unit mL/min/1.73m^2) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening, Multiply it by BSA, then divide by 1.73 to convert to absolute GFR (unit, mL/min) (group A1) mild renal impairment (60 ≤ GFR< 90 mL/min); (group B1) moderate renal impairment (30 ≤ GFR<60 mL/min); (group C1) severe renal impairment (15 ≤ GFR< 30 mL/min); (group D1) kidney failure (<15 mL/min, not on hemodialysis); (group A2,B2,C2,D2) control subjects with normal renal function will be matched with subjects with renal impairment by weight, age, and sex (GFR≥90 mL/min).If subjects in group A2 can be matched with the subjects in groups A1 and B1 at the same time, the subjects in group B2 will not be enrolled, and so on.
Approximately 64 subjects will be enrolled in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mild Renal Impairment | Experimental | Drug: HSK7653 tabletsA1 group subjects will receive a single dose of 10 mg HSK7653 |
| Moderate Renal Impairment | Experimental | Drug: HSK7653 tabletsB1 group subjects will receive a single dose of 10 mg HSK7653 |
| Severe Renal Impairment | Experimental | Drug: HSK7653 tabletsC1 group subjects will receive a single dose of 10 mg HSK7653 |
| Kidney failure | Experimental | Drug: HSK7653 tabletsD1 group subjects will receive a single dose of 10 mg HSK7653 |
| Normal Renal function | Experimental | Drug: HSK7653 tabletsA2, B2, C2 and D2 group subjects will receive a single dose of 10 mg HSK7653, If the age, sex and weight of the subjects in group A2 can be matched with the subjects in groups A1 and B1 at the same time, the subjects in group B2 will not be enrolled, and so on. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;
- 18 years to 79 years (inclusive), male and female;
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m^2));
- Subjects with medically stable RI until study completion corresponding to the Classifications of Renal Function based on GFR: mild RI: 60≤GFR<90 mL/min; moderate RI: 30≤GFR<60 mL/min, severe RI:15≤GFR<30 mL/min, kidney failure:GFR<15 mL/min (not on hemodialysis);
- Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests (hematology, serum chemistry, coagulation and urinalysis test) results were deemed appropriate by the investigator;
Key exclusion criteria (17 listed)
- Subjects who have a allergic history of DPP4 inhibitors or have a history of allergy to the test drug and the related compounds;
- Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening；
- History or clinical evidence of acute or chronic pancreatitis, or clinically significant abnormalities in blood lipase and/or blood amylase results at screening;
- Have conditions that may affect drug absorption, distribution, metabolism, or excretion (e.g., disease, drugs or surgery);
- Use of any DPP-IV enzyme inhibitor within 2 weeks prior to the 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 |
|---|---|---|
| HSK7653 tabletsAlso: HSK7653HSK7653, tablet, oral | Drug | Kidney failure, Mild Renal Impairment, Moderate Renal Impairment, Normal Renal function, Severe Renal Impairment |
Primary outcome
Cmax
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
The pharmacokinetic parameters of HSK7653 in plasma
AUC0-t
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
The pharmacokinetic parameters of HSK7653 in plasma
AUC0-inf
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
The pharmacokinetic parameters of HSK7653 in plasma
11 secondary outcomes
Tmax
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
t1/2
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
Vz/F
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
CL/F
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing
Ae
Time frame: Predose and 168 hours after dosing
Fe
Time frame: Predose and 168 hours after dosing
CLr
Time frame: Predose and 168 hours after dosing
DPP4 inhibition AUEC
Time frame: Predose and 1, 24, 72, 168, 336 hours after dosing
DPP4 inhibition Emax
Time frame: Predose and 1, 24, 72, 168, 336 hours after dosing
DPP4 inhibition E336h
Time frame: Predose and 1, 24, 72, 168, 336 hours after dosing
The number of volunteers with adverse events as a measure of safety
Time frame: Day 1 to Day 32
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 3 Jan 2023.
- Derived from this study: PubMed 38184489Shi D, Chen L, Li G, Wu N, Zhang F, Wang X, Mu N, Chen X, Yang X, Lu J, Lu Y, Wang M, Zhang D. Pharmacokinetics, Pharmacodynamics, and Safety of Single Dose HSK7653 Tablets in Chinese Subjects with Normal or Impaired Renal Function. Clin Pharmacokinet. 2024 Feb;63(2):227-239. doi: 10.1007/s40262-023-01333-4. Epub 2024 Jan 6.
- 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.
Wang Meixia principal investigator
Beijing Jishuitan Hospital
Zhang dongliang principal investigator
Beijing Jishuitan Hospital
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 HSK7653 tablets in people with Renal Impairment, run by Haisco Pharmaceutical Group 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 16 inclusion and 17 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 3 Jan 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?
Cmax (time frame: Predose and 0.25, 0.5, 1, 2, 4, 8 , 12, 24, 72, 168, 336, 504, 672 hours after dosing). 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 NCT05497297, 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 3 Jan 2023.