Renal InsufficiencyPhase 1NCT02815774
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients
A Phase 1 study testing SP2086 in people with Renal Insufficiency, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- SP2086
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2015
- 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
- with a body mass index(BMI) between 19 and 28 Kg/m2;Weight:≥50Kg(male),≥45kg(female)
- The endogenous creatinine clearance of subjects in groups must meet the standards of Ccr in renal function in installment:mild renal insufficiency:60-89 - ml/min;Moderate renal insufficiency: 30 to 59 ml/min;Severe renal insufficiency: 15-29 ml/min;End-stage renal disease: < 15 ml/min.Normal renal function: 90 ml/min or more.
- Had signed the informed consent himself or herself voluntarily.
Who cannot join
- Cannot tolerate oral medicine.
- Not control or unstable cardiovascular, respiratory, liver, digestive, endocrine, hematopoietic, the mental or nerve system diseases.
- Had the digestive surgery that could affect drug absorption.
- The clinical significance of arrhythmia.
- Acute hepatitis, chronic liver disease; ALT or AST value was 2 times greater than upper normal limit, Total bilirubin value was 1.5 times greater than upper normal limit.
- HBV surface antigen, HCV antibody, or HIV antibody was positive.
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- history of drug allergy or allergic constitution or family history of allergy.
- Had Used hormonal contraception within 3 months;
- Had Used DPP - IV inhibitor within 2 weeks;
- Had Used traditional Chinese medicine (Chinese herbs, Chinese patent medicine) within 2 weeks;
- Had Used acid inhibitors within 2 weeks;
- Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.
- 2 days before the randomization till to the end ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion
- The patient had participated three times or more clinical trial in one year, or one time within 3 months.
- Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
- History of blood donation or participate in blood donation, or by blood transfusion in 3 months prior to screening.
- Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
About this study
Official title: A Parallel, Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients
The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.
Read the detailed description
This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.
- Conditions
- Renal Insufficiency
- Being tested
- SP2086
- Keywords
- SP2086, Renal Insufficiency, Pharmacokinetic
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP2086Drug
all subjects were given SP2086 50mg only one time.
| Study group | Role | What they receive |
|---|---|---|
| health volunteers | Active comparator | this group patients were given SP2086 50mg only one time. Receives: Drug: SP2086 |
| mild renal insufficiency | Active comparator | this group patients were given SP2086 50mg only one time. Receives: Drug: SP2086 |
| moderate renal insufficiency | Active comparator | this group patients were given SP2086 50mg only one time. Receives: Drug: SP2086 |
| severe renal insufficiency | Active comparator | this group patients were given SP2086 50mg only one time. Receives: Drug: SP2086 |
| end-stage renal insufficiency | Active comparator | this group patients were given SP2086 50mg only one time. Receives: Drug: SP2086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of SP2086
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
Measured: up to 96 hours
The maximum plasma concentration (Cmax) of SP2086 acid
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
Measured: up to 96 hours
The area under the plasma concentration-time curve (AUC) of SP2086
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
Measured: up to 96 hours
The area under the plasma concentration-time curve (AUC) of SP2086 acid
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
Measured: up to 96 hours
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia Miao, P.H.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815774
- Sponsor's protocol ID
- HR-SP2086-Ih
- Status last verified
- Jun 2016
- First submitted
- 3 Jan 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients
- ClinicalTrials.gov ID
- NCT02815774
- Acronym / sponsor ID
- HR-SP2086-Ih
- Conditions
- Renal Insufficiency
- Keywords
- SP2086, Renal Insufficiency, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Jun 2016 (estimated)
- 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 the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.
Detailed description
This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| health volunteers | Active comparator | Drug: SP2086this group patients were given SP2086 50mg only one time. |
| mild renal insufficiency | Active comparator | Drug: SP2086this group patients were given SP2086 50mg only one time. |
| moderate renal insufficiency | Active comparator | Drug: SP2086this group patients were given SP2086 50mg only one time. |
| severe renal insufficiency | Active comparator | Drug: SP2086this group patients were given SP2086 50mg only one time. |
| end-stage renal insufficiency | Active comparator | Drug: SP2086this group patients were given SP2086 50mg only one time. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with a body mass index(BMI) between 19 and 28 Kg/m2;Weight:≥50Kg(male),≥45kg(female)
- The endogenous creatinine clearance of subjects in groups must meet the standards of Ccr in renal function in installment:mild renal insufficiency:60-89 - ml/min;Moderate renal insufficiency: 30 to 59 ml/min;Severe renal insufficiency: 15-29 ml/min;End-stage renal disease: < 15 ml/min.Normal renal function: 90 ml/min or more.
- Had signed the informed consent himself or herself voluntarily.
Key exclusion criteria (17 listed)
- Cannot tolerate oral medicine.
- Not control or unstable cardiovascular, respiratory, liver, digestive, endocrine, hematopoietic, the mental or nerve system diseases.
- Had the digestive surgery that could affect drug absorption.
- The clinical significance of arrhythmia.
- Acute hepatitis, chronic liver disease; ALT or AST value was 2 times greater than upper normal limit, Total bilirubin value was 1.5 times greater than upper normal limit.
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 |
|---|---|---|
| SP2086all subjects were given SP2086 50mg only one time. | Drug | end-stage renal insufficiency, health volunteers, mild renal insufficiency, moderate renal insufficiency, severe renal insufficiency |
Primary outcome
The maximum plasma concentration (Cmax) of SP2086
Time frame: up to 96 hours
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to 96 hours
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086
Time frame: up to 96 hours
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to 96 hours
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to 96 hours
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 28 Jun 2016.
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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.
Jia Miao, P.H.D principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP2086 in people with Renal Insufficiency, 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 3 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 28 Jun 2016. 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?
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?
The maximum plasma concentration (Cmax) of SP2086 (time frame: up to 96 hours). The study lists 4 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 28 Jun 2016.