Subjects With Impaired Renal Function and Healthy SubjectsPhase 1NCT04414852
A Study to Evaluate the Pharmacokinetics of Apatinib in Subjects With Impaired Renal Function
A Phase 1 study testing Apatinib Mesylate in people with Subjects With Impaired Renal Function and Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects with impaired renal function and healthy subjects, to give dose recommendations for patients with impaired renal function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Impaired Renal Function and Healthy Subjects
- What is being tested?
- Apatinib Mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2020to 30 Apr 2021
- 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
- for subjects with impaired renal function
- Able to comprehend and willing to sign an informed consent form (ICF)
- 18-70 years of age.
- 19 kg/m2<BMI <19-28 kg/m2
- eGFR (MDRD equation) for mild impaired renal function: 60-89 mL/min/1.73 m2 eGFR (MDRD equation) for moderate impaired renal function: 30-59 mL/min/1.73 m2
- In good health, except for kidney disease and complications, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
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- Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
- for healthy subjects:
- Able to comprehend and willing to sign an informed consent form (ICF)
- 18-70 years of age.
- 19 kg/m2<BMI <19-28 kg/m2
- eGFR (MDRD equation) for mild impaired renal function: ≥90mL/min/1.73 m2
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
- Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
Who cannot join
- for subjects with renal impairment
- Renal allograft recipients;
- Need hemodialysis during study;
- Uroclepsia or anuria;
- Allergic to apatinib or ingredients;
- History of heart disease in 12 months before study;
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- Coagulation disorders;
- Hypertension and could not be controlled with hypotensor;
- With hepatic or archenteric disease;
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL, or receive blood transfusion, or donate blood volume≥200mL within 1 month prior dosing.
- Take any clinical trial drugs within 3 months prior dosing;
- Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days before dosing;
- Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit = 285 mL of beer, or 100mL of wine), or take ≥5 cigarettes;
- Positive in urine drug test;
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or grapefruit-containing products from 48 hours before dosing to the end of the study;
- The investigator believes that the subjects are not eligible to participate in this trial.
- for healthy subjects:
- Renal allograft recipients;
- Allergic to apatinib or ingredients;
- History of heart disease in 12 months before study;
- Coagulation disorders;
- Hypertension and could not be controlled with hypotensor;
- With hepatic or archenteric disease;
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL, or receive blood transfusion, or donate blood volume≥200mL within 1 month prior dosing.
- Take any clinical trial drugs within 3 months prior dosing;
- Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days before dosing;
- Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit =285 mL of beer, or 100mL of wine), or take ≥5 cigarettes;
- Positive in urine drug test;
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or grapefruit-containing products from 48 hours before dosing to the end of the study;
- The investigator believes that the subjects are not eligible to participate in this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Non-randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetics of Apatinib Mesylate in Subjects With Impaired Renal Function and Healthy Subjects
The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects with impaired renal function and healthy subjects, to give dose recommendations for patients with impaired renal function.
- Being tested
- Apatinib Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
All the subjects will be administrated with 250mg apatinib on day 1
| Study group | Role | What they receive |
|---|---|---|
| mild renal impairment | Experimental | Not described Receives: Drug: Apatinib Mesylate |
| moderate remal impairment | Experimental | Not described Receives: Drug: Apatinib Mesylate |
| normal renal impairment | Active comparator | Not described Receives: Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 0-96 hours
AUC0-t
Area under the plasma concentration versus time curve from zero to 96h
Measured: 0-96 hours
AUC0-∞
Area under the plasma concentration versus time curve from zero to infinity
Measured: 0-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start5 Jun 2020 (estimated)
- Primary completion15 Jan 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Impaired Renal Function and Healthy SubjectsStudies 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
- Other
- 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
- NCT04414852
- Sponsor's protocol ID
- HR-APTN-I-011
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetics of Apatinib Mesylate in Subjects With Impaired Renal Function and Healthy Subjects
- ClinicalTrials.gov ID
- NCT04414852
- Acronym / sponsor ID
- HR-APTN-I-011
- 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
- 5 Jun 2020 (estimated)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects with impaired renal function and healthy subjects, to give dose recommendations for patients with impaired renal function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild renal impairment | Experimental | Drug: Apatinib Mesylate |
| moderate remal impairment | Experimental | Drug: Apatinib Mesylate |
| normal renal impairment | Active comparator | Drug: Apatinib Mesylate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- for subjects with impaired renal function
- Able to comprehend and willing to sign an informed consent form (ICF)
- 18-70 years of age.
- 19 kg/m2<BMI <19-28 kg/m2
- eGFR (MDRD equation) for mild impaired renal function: 60-89 mL/min/1.73 m2 eGFR (MDRD equation) for moderate impaired renal function: 30-59 mL/min/1.73 m2
Key exclusion criteria (32 listed)
- for subjects with renal impairment
- Renal allograft recipients;
- Need hemodialysis during study;
- Uroclepsia or anuria;
- Allergic to apatinib or ingredients;
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 |
|---|---|---|
| Apatinib MesylateAll the subjects will be administrated with 250mg apatinib on day 1 | Drug | mild renal impairment, moderate remal impairment, normal renal impairment |
Primary outcome
Cmax
Time frame: 0-96 hours
Maximum plasma concentration
AUC0-t
Time frame: 0-96 hours
Area under the plasma concentration versus time curve from zero to 96h
AUC0-∞
Time frame: 0-96 hours
Area under the plasma concentration versus time curve from zero to infinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib Mesylate in people with Subjects With Impaired Renal Function and Healthy Subjects, 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 14 inclusion and 32 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 4 Jun 2020. 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 Yuya Wang (13918749176, wangyuya@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0-96 hours). 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 4 Jun 2020.