Complicated Urinary Tract Infection; CutiPhase 1NCT04476407
Pharmacokinetics of Benapenem in Subjects With Renal Impairment
A Phase 1 study testing benapenem in people with Complicated Urinary Tract Infection; Cuti, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Complicated Urinary Tract Infection; Cuti
- What is being tested?
- benapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2019to 21 Oct 2019
- 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
- 1.18~75 years old
- 2. BMI 17 to 30 kg/m2
- 3. No known diseases or significant abnormalities on physical exam (subjects with normal renal function only)
- 4. eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only)
- 5. eGFR 30 to 59 mL/min/1.73m2 (subjects with mild renal impairment only); eGFR 60 to 89 mL/min/1.73m2 (subjects with moderate renal impairment only)
Who cannot join
- 1. Hypersensitivity to any of the beta-lactam antibiotics
- 2.Conditions or disease that may interfere with the evaluation of study drug
- 3. Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration;
- 4. Drug abuse in 2 years
- 5. A blood donation or more than 400 ml of blood loss within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)
- Being tested
- benapenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benapenemDrug
single-dose Benapenem 1.0mg(iv), 60min infusion
benapenemDrug
single-dose Benapenem 1.0mg(iv), 60min infusion
benapenemDrug
single-dose Benapenem 1.0mg(iv), 60min infusion
| Study group | Role | What they receive |
|---|---|---|
| G1 | Experimental | subjects with nomal renal function Receives: Drug: benapenem |
| G2 | Experimental | subjects with mild renal impairment Receives: Drug: benapenem |
| G3 | Experimental | subjects with moderate renal impairment Receives: Drug: benapenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve from time 0 to the time of thelast quantifiable concentration (AUC0-t )of benapenem and the metabolite
Measured: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve from time 0 to infinity ( AUC0-inf ) of benapenem and the metabolite
Measured: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
Maximum observed plasma concentration(Cmax)
Maximum observed plasma concentration(Cmax) of benapenem and the metabolite
Measured: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
Observed terminal elimination half-life (T1/2)
Observed terminal elimination half-life (T1/2) of benapenem and its metabolite
Measured: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Total body clearance (CLt)
Total body clearance (CLt) of benapenem
Measured: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Apparent volume of distribution (Vz)
Apparent volume of distribution (Vz) based on the terminal phase of benapenem
Measured: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Cumulative urine exeretion
Cumulative urine exeretion (Ae0-72h%) of benapenem and its metabolite
Measured: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Renal clearance (CLr)
Renal clearance (CLr) of Benapenem and its metabolite
Measured: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Metabolite-to-parent ratio of AUC0-inf
Metabolite-to-parent ratio of AUC0-inf (MR)
Measured: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Jun 2019
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract Infection; CutiStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476407
- Sponsor's protocol ID
- 5081-I-1004
- Status last verified
- Apr 2019
- First submitted
- 15 Jul 2020
- Last updated
- 20 Jul 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 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "
- ClinicalTrials.gov ID
- NCT04476407
- Acronym / sponsor ID
- 5081-I-1004
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 20 Jul 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.
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1 | Experimental | Drug: benapenemsubjects with nomal renal function |
| G2 | Experimental | Drug: benapenemsubjects with mild renal impairment |
| G3 | Experimental | Drug: benapenemsubjects with moderate renal impairment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.18~75 years old
- 2. BMI 17 to 30 kg/m2
- 3. No known diseases or significant abnormalities on physical exam (subjects with normal renal function only)
- 4. eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only)
- 5. eGFR 30 to 59 mL/min/1.73m2 (subjects with mild renal impairment only); eGFR 60 to 89 mL/min/1.73m2 (subjects with moderate renal impairment only)
Key exclusion criteria (5 listed)
- 1. Hypersensitivity to any of the beta-lactam antibiotics
- 2.Conditions or disease that may interfere with the evaluation of study drug
- 3. Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration;
- 4. Drug abuse in 2 years
- 5. A blood donation or more than 400 ml of blood loss within 3 months
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 |
|---|---|---|
| benapenemsingle-dose Benapenem 1.0mg(iv), 60min infusion | Drug | G1 |
| benapenemsingle-dose Benapenem 1.0mg(iv), 60min infusion | Drug | G2 |
| benapenemsingle-dose Benapenem 1.0mg(iv), 60min infusion | Drug | G3 |
Primary outcome
Area under the plasma concentration-time curve
Time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
Area under the plasma concentration-time curve from time 0 to the time of thelast quantifiable concentration (AUC0-t )of benapenem and the metabolite
Area under the plasma concentration-time curve
Time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity ( AUC0-inf ) of benapenem and the metabolite
Maximum observed plasma concentration(Cmax)
Time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
Maximum observed plasma concentration(Cmax) of benapenem and the metabolite
Observed terminal elimination half-life (T1/2)
Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Observed terminal elimination half-life (T1/2) of benapenem and its metabolite
Total body clearance (CLt)
Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Total body clearance (CLt) of benapenem
Apparent volume of distribution (Vz)
Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Apparent volume of distribution (Vz) based on the terminal phase of benapenem
Cumulative urine exeretion
Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Cumulative urine exeretion (Ae0-72h%) of benapenem and its metabolite
Renal clearance (CLr)
Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Renal clearance (CLr) of Benapenem and its metabolite
Metabolite-to-parent ratio of AUC0-inf
Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Metabolite-to-parent ratio of AUC0-inf (MR)
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 20 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 benapenem in people with Complicated Urinary Tract Infection; Cuti, run by Sihuan Pharmaceutical Holdings Group 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 5 inclusion and 5 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 20 Jul 2020. 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?
Area under the plasma concentration-time curve (time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose). The study lists 9 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 20 Jul 2020.