DiabetesPhase 1NCT06035406
A Trial of SP2086 With Hepatic Insufficiency
A Phase 1 study testing Retagliptin Phosphate Tablet in people with Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Retagliptin Phosphate Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; And be able to complete the research according to the requirements of the test plan;
- The subjects (including their partners) are willing to voluntarily take effective contraceptive measures from screening until 2 weeks after the last study drug administration, as specified in Appendix 1;
- Age 18-70 years old (including the critical value), both male and female;
- The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body mass index (BMI) : 18-32 kg/m2 (including the cut-off value);
- (Only for subjects with normal liver function) The demographic mean of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
- The body weight was matched with that of the liver function impairment group (group A + group B), with an average of ±10 kg;
Show all 12Show fewer
- Age matching was performed with the liver function impairment group (group A + group B), and the mean was ±10 years old;
- Gender matching was performed with the liver function impairment group (group A + group B), with an average of ±1 cases;
- (Only for subjects with normal liver function) Normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) have no clinical significance.
- (Only for subjects with normal liver function) No prior serious primary diseases of major organs, including but not limited to gastrointestinal, respiratory, kidney, liver, nervous, blood, endocrine, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases
- (Only for subjects with liver function impairment) Those who had not taken medication within 4 weeks prior to screening, or who had at least 4 weeks of stable medication for liver impairment and/or other comorbidification requiring long-term treatment
- (Only for subjects with liver function impairment) Patients with liver insufficiency due to previous primary liver disease with Child-Pugh grade A or B.
Who cannot join
- allergy, or known or suspected allergy to any of the ingredients in the investigational drug;
- Smoking an average of more than 10 cigarettes per day in the 3 months before screening;
- Alcoholics in the preceding 3 months, i.e. drinking more than 14 units of alcohol per week (1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine);
- Drug abusers or drug urine screening test positive;
- Blood donation or blood loss ≥400 mL within 3 months before screening, or receiving blood transfusion;
- Major surgery or surgical incision not fully healed within 6 months prior to screening;
Show all 24Show fewer
- Had been exposed to DPP-IV inhibitors such as sitagliptin, saxagliptin, ligagliptin, vigagliptin within 1 month prior to administration;
- Chinese herbal medicine was taken within 2 weeks before administration;
- Have malignant tumors, or a history of malignant tumors within 5 years prior to screening (except for treated non-melanoma skin tumors with no signs of recurrence, and resected cervical intraepithelial neoplasia);
- Patients with a history of severe hypoglycemia;
- History of recurrent urinary tract infections or/and genital fungal infections;
- Those who are expected to have a tendency to undergo surgery or be hospitalized during the trial;
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening;
- 14.12- Patients with clinically significant ECG abnormalities (such as tachycardia/bradycardia requiring medical treatment, degree II-III atrioventricular block, or QTcF (male) ≥470ms, QTcF (female) ≥480ms), or other clinically significant abnormalities determined by the investigator and judged by the investigator to be unsuitable for participation in this study;
- Female subjects were breastfeeding or had positive pregnancy results during the screening period or during the test;
- 16. Serum creatinine values were estimated glomerular filtration rate calculated using the chronic kidney disease epidemiology collaboration CKD-EPI formula filtration rate eGFR) < 90 ml/min;
- 17. Anyone who has consumed any food or drink containing alcohol (or positive breath test for alcohol), grapefruit juice/grapefruit juice, methylxanthine (such as coffee, tea, cola, chocolate, energy drinks), strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion or other factors within 2 days prior to administration;
- 18 Those who had any factors deemed inappropriate by the investigator to participate in the study.
- (Only for subjects with normal liver function) Participants who have participated in clinical trials of any drug or medical device within 3 months prior to screening (subject to acceptance of the drug)
- (Only for subjects with normal liver function) Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or syphilis antibody detection of any index screening positive excluded.
- (Only for subjects with liver function impairment) Participants who have participated in clinical trials of any drug or medical device within 1 month prior to screening (subject to acceptance of the drug)
- (Only for subjects with liver function impairment) A history of liver transplantation
- (Only for subjects with liver function impairment) Subjects with liver failure, or liver cirrhosis with complications such as hepatic encephalopathy, hepatocellular carcinoma, esophageal variceal hemorrhage and other complications deemed inappropriate by the researchers to participate in the study
- (Only for subjects with liver function impairment) In addition to the primary liver disease itself, a history of any serious disease, or a medical history or abnormalities that the investigator believes may affect the results of the trial, and/or clinically significant clinical laboratory tests, including, but not limited to, a history of circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, and metabolic disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pharmacokinetics and Safety of SP2086 in Subjects With Mild and Moderate Liver Impairment and Normal Liver Function.
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Conditions
- Diabetes
- Being tested
- Retagliptin Phosphate Tablet
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retagliptin Phosphate TabletDrug
Retagliptin Phosphate Tablet;100mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: Retagliptin Phosphate Tablet | Experimental | Not described Receives: Drug: Retagliptin Phosphate Tablet |
| Treatment group B: Retagliptin Phosphate Tablet | Experimental | Not described Receives: Drug: Retagliptin Phosphate Tablet |
| Treatment group C: Retagliptin Phosphate Tablet | Experimental | Not described Receives: Drug: Retagliptin Phosphate Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters：Cmax；
Measured: 0hour to 72hours after the last dosing
PK parameters：AUC0-t；
Measured: 0hour to 72hours after the last dosing
PK parameters：AUC0-∞；
Measured: 0hour to 72hours after the last dosing
Secondary outcomes (5)
PK parameters：Tmax；
Measured: 0hour to 72hours after the last dosing
PK parameters：t1/2；
Measured: 0hour to 72hours after the last dosing
PK parameters：CL/F；
Measured: 0hour to 72hours after the last dosing
PK parameters：V/F；
Measured: 0hour to 72hours after the last dosing
Incidence and severity of adverse events (AEs)
Measured: from screening to 168 hours after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035406
- Sponsor's protocol ID
- SP2086-117
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of SP2086 in Subjects With Mild and Moderate Liver Impairment and Normal Liver Function.
- ClinicalTrials.gov ID
- NCT06035406
- Acronym / sponsor ID
- SP2086-117
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Sep 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 used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: Retagliptin Phosphate Tablet | Experimental | Drug: Retagliptin Phosphate Tablet |
| Treatment group B: Retagliptin Phosphate Tablet | Experimental | Drug: Retagliptin Phosphate Tablet |
| Treatment group C: Retagliptin Phosphate Tablet | Experimental | Drug: Retagliptin Phosphate Tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; And be able to complete the research according to the requirements of the test plan;
- The subjects (including their partners) are willing to voluntarily take effective contraceptive measures from screening until 2 weeks after the last study drug administration, as specified in Appendix 1;
- Age 18-70 years old (including the critical value), both male and female;
- The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body mass index (BMI) : 18-32 kg/m2 (including the cut-off value);
- (Only for subjects with normal liver function) The demographic mean of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
Key exclusion criteria (24 listed)
- allergy, or known or suspected allergy to any of the ingredients in the investigational drug;
- Smoking an average of more than 10 cigarettes per day in the 3 months before screening;
- Alcoholics in the preceding 3 months, i.e. drinking more than 14 units of alcohol per week (1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine);
- Drug abusers or drug urine screening test positive;
- Blood donation or blood loss ≥400 mL within 3 months before screening, or receiving blood transfusion;
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 |
|---|---|---|
| Retagliptin Phosphate TabletRetagliptin Phosphate Tablet;100mg | Drug | Treatment group A: Retagliptin Phosphate Tablet, Treatment group B: Retagliptin Phosphate Tablet, Treatment group C: Retagliptin Phosphate Tablet |
Primary outcome
PK parameters：Cmax；
Time frame: 0hour to 72hours after the last dosing
PK parameters：AUC0-t；
Time frame: 0hour to 72hours after the last dosing
PK parameters：AUC0-∞；
Time frame: 0hour to 72hours after the last dosing
5 secondary outcomes
PK parameters：Tmax；
Time frame: 0hour to 72hours after the last dosing
PK parameters：t1/2；
Time frame: 0hour to 72hours after the last dosing
PK parameters：CL/F；
Time frame: 0hour to 72hours after the last dosing
PK parameters：V/F；
Time frame: 0hour to 72hours after the last dosing
Incidence and severity of adverse events (AEs)
Time frame: from screening to 168 hours after the last dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retagliptin Phosphate Tablet in people with Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
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 12 inclusion and 24 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Sheng Feng (+86-0518-82342973, sheng.feng@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters：Cmax； (time frame: 0hour to 72hours after the last 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?
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 13 Sep 2023.