Bacterial InfectionsPhase 1NCT04787562
Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function
A Phase 1 study testing XNW4107, Imipenem/Cilastatin in people with Bacterial Infections, run by Evopoint Biosciences Inc. at 2 sites in United States.
Trial summary
This is a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- XNW4107, Imipenem/Cilastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2021to 28 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult males or females, 18 years of age or older.
- 2. BMI ≥ 18.5 and ≤ 39.9 (kg/m²) and weight between 50.0 and 130.0 kg (inclusive).
- 3. Medically healthy (Cohort 1 only) or medically stable without clinically significant acute or chronic illness (Cohorts 2-5) that may impact the assessment of PK and safety.
- 4. Normal renal function with eGFR ≥90 mL/min/1.73m² (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m² (Cohort 2), 30 to <60 mL/min/1.73m² (Cohort 3), or 15 to <30 mL/min/1.73m² (Cohort 4), ESRD receiving HDs at least 3 times per week for at least 3 months at Screening (Cohort 5)
- 5. Participants of reproductive potential (male or female) must be willing to use contraception.
- 6. Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food or product containing any of these from 48 hours prior to study drug administration until discharge from the clinical unit.
Who cannot join
- 1. Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests.
- 2. Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec obtained at Screening or Check-In.
- 3. Results for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 × the upper limit of normal (ULN) for the reference laboratory.
- 4. History of chronic liver disease, cirrhosis, or biliary disease.
- 5. History or presence of CNS disorders, seizures, or other CNS adverse reactions such as confusional states and myoclonic activity.
- 6. Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening.
Show all 17Show fewer
- 7. Close contact with anyone who tested positive for SARS-CoV-2 infection, or presence of symptoms associated with SARS-CoV-2 infection at Screening or Check-in, or within 14 days prior to Screening.
- 8. Recent history (within 6 months) of known or suspected Clostridium difficile infection.
- 9. Positive testing for HIV Ab, HBsAg or HCV Ab.
- 10. Recent history of substance or alcohol abuse within the previous year, or habitual use of tobacco or nicotine products or smoking within 3 months prior to Screening.
- 11. Positive drug screen and alcohol testing at Screening or Check-in.
- 12. For subjects with normal renal function (Cohort 1), the use of any over-the-counter (OTC) medications within 7 days prior to study drug administration or use of prescription medications including nonsteroidal anti-inflammatory drugs, health supplements, and herbal remedies taken within 13 days prior to study drug administration.
- 13. For subjects with renal impairment (Cohorts 2-5), the use of prohibited concomitant medication with the exception of those essential for the management of renal impairment and other concomitant stable medical conditions as per the discretion of the Investigator.
- 14. Use of probenecid or valproic acid within 30 days prior to study drug administration.
- 15. Receipt of an investigational drug within 30 days or 5 half-lives prior to the first administration of study drug, whichever is longer.
- 16. Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication, or history of clinically significant hypersensitivity to the study drug or any related drugs or to any of the excipients, or history of food intolerance.
- 17. Donation of blood or plasma within 30 days prior to dosing, or loss of whole blood of more than 500 mL within 30 days prior to dosing, or receipt of a blood transfusion within 1 year of study enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Clinical Pharmacology (DCP), University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809-3017
About this study
Official title: A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF XNW4107, IMIPENEM AND CILASTATIN ADMINISTERED CONCURRENTLY AS INTRAVENOUS INFUSION TO SUBJECTS WITH VARIOUS DEGREES OF RENAL FUNCTION
This is a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to subjects with normal renal function.
- Conditions
- Bacterial Infections
- Being tested
- XNW4107, Imipenem/Cilastatin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XNW4107, Imipenem/CilastatinDrug
Drug: XNW4107 250mg IV over 60 minutes as a single dose
Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
XNW4107, Imipenem/CilastatinDrug
Drug: XNW4107 250mg IV over 60 minutes as a single dose
Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
XNW4107, Imipenem/CilastatinDrug
Drug: XNW4107 250mg IV over 60 minutes as a single dose
Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
XNW4107, Imipenem/CilastatinDrug
Drug: XNW4107 100mg IV over 60 minutes as a single dose
Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose
XNW4107, Imipenem/CilastatinDrug
Drug: XNW4107 100mg IV over 60 minutes as a single dose
Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: normal renal function | Experimental | Participants with an eGFR ≥ 90 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg Receives: Drug: XNW4107, Imipenem/Cilastatin |
| Cohort 2: Mild renal insufficiency | Experimental | Participants with an eGFR 60 to <90 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg Receives: Drug: XNW4107, Imipenem/Cilastatin |
| Cohort 3: Moderate renal insufficiency | Experimental | Participants with an eGFR 30 to <60 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg Receives: Drug: XNW4107, Imipenem/Cilastatin |
| Cohort 4: Severe renal insufficiency | Experimental | Participants with an eGFR 15 to <30 mL/min/1.73m2 receive a single dose of XNW4107 100mg IV co-administered with imipenem 200mg /cilastatin 200mg Receives: Drug: XNW4107, Imipenem/Cilastatin |
| Cohort 5: End-stage renal disease (ESRD) receiving hemodialysis (HD) therapy | Experimental | Participants with ESRD receiving HD therapy at least 3 times a week for at least 3 months prior to Screening visit receive a single dose of XNW4107 100mg IV co-administered with imipenem 200mg /cilastatin 200mg Receives: Drug: XNW4107, Imipenem/Cilastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body clearance (CL) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Measured: From baseline to 48 hours post-dose
Apparent steady-state volume of distribution (Vss) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Measured: From baseline to 48 hours post-dose
Area under the curve from time zero to infinity (AUC0-∞)of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Measured: From baseline to 48 hours post-dose
Maximum plasma concentration (Cmax) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Measured: From baseline to 48 hours post-dose
Time to the maximum plasma concentration (Tmax) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Measured: From baseline to 48 hours post-dose
The terminal elimination half-life (t1/2) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Measured: From baseline to 48 hours post-dose
Secondary outcomes (1)
Adverse event (include SAEs) will be assessed and categorized.
Safety and tolerability up to the last study visit as assessed by the percentage of treatment-emergent AEs [including serious adverse events (SAEs)] categorized by severity, relationship to study drug, system organ class (SOC), AE preferred term (PT), along with percentage of clinically significant changes from baseline in clinical laboratory values, physical examination, vital signs, and ECG parameters.
Measured: From baseline up to 10 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start25 Feb 2021
- Primary completion30 Oct 2021
- Study completion28 Feb 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 Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Evopoint Biosciences Inc.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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Le, Study chair, Evopoint Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787562
- Sponsor's protocol ID
- XNW4107-003
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodvold KA, Mamikonyan G, Wang Y, McRoberts A, Garg D, Preston R, Marabury T, Le M, Li J. Impact of renal impairment on pharmacokinetics, safety, and tolerability of funobactam, combined with imipenem and cilastatin. Antimicrob Agents Chemother. 2026 Aug 27:e0080826. doi: 10.1128/aac.00808-26. Online ahead of print.
PubMed 42657892
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF XNW4107, IMIPENEM AND CILASTATIN ADMINISTERED CONCURRENTLY AS INTRAVENOUS INFUSION TO SUBJECTS WITH VARIOUS DEGREES OF RENAL FUNCTION
- ClinicalTrials.gov ID
- NCT04787562
- Acronym / sponsor ID
- XNW4107-003
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 8 Mar 2021 (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 a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to subjects with normal renal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: normal renal function | Experimental | Drug: XNW4107, Imipenem/CilastatinParticipants with an eGFR ≥ 90 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg |
| Cohort 2: Mild renal insufficiency | Experimental | Drug: XNW4107, Imipenem/CilastatinParticipants with an eGFR 60 to <90 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg |
| Cohort 3: Moderate renal insufficiency | Experimental | Drug: XNW4107, Imipenem/CilastatinParticipants with an eGFR 30 to <60 mL/min/1.73m2 receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg |
| Cohort 4: Severe renal insufficiency | Experimental | Drug: XNW4107, Imipenem/CilastatinParticipants with an eGFR 15 to <30 mL/min/1.73m2 receive a single dose of XNW4107 100mg IV co-administered with imipenem 200mg /cilastatin 200mg |
| Cohort 5: End-stage renal disease (ESRD) receiving hemodialysis (HD) therapy | Experimental | Drug: XNW4107, Imipenem/CilastatinParticipants with ESRD receiving HD therapy at least 3 times a week for at least 3 months prior to Screening visit receive a single dose of XNW4107 100mg IV co-administered with imipenem 200mg /cilastatin 200mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Adult males or females, 18 years of age or older.
- 2. BMI ≥ 18.5 and ≤ 39.9 (kg/m²) and weight between 50.0 and 130.0 kg (inclusive).
- 3. Medically healthy (Cohort 1 only) or medically stable without clinically significant acute or chronic illness (Cohorts 2-5) that may impact the assessment of PK and safety.
- 4. Normal renal function with eGFR ≥90 mL/min/1.73m² (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m² (Cohort 2), 30 to <60 mL/min/1.73m² (Cohort 3), or 15 to <30 mL/min/1.73m² (Cohort 4), ESRD receiving HDs at least 3 times per week for at least 3 months at Screening (Cohort 5)
- 5. Participants of reproductive potential (male or female) must be willing to use contraception.
Key exclusion criteria (17 listed)
- 1. Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests.
- 2. Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec obtained at Screening or Check-In.
- 3. Results for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 × the upper limit of normal (ULN) for the reference laboratory.
- 4. History of chronic liver disease, cirrhosis, or biliary disease.
- 5. History or presence of CNS disorders, seizures, or other CNS adverse reactions such as confusional states and myoclonic activity.
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 |
|---|---|---|
| XNW4107, Imipenem/CilastatinDrug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose | Drug | Cohort 1: normal renal function |
| XNW4107, Imipenem/CilastatinDrug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose | Drug | Cohort 2: Mild renal insufficiency |
| XNW4107, Imipenem/CilastatinDrug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose | Drug | Cohort 3: Moderate renal insufficiency |
| XNW4107, Imipenem/CilastatinDrug: XNW4107 100mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose | Drug | Cohort 4: Severe renal insufficiency |
| XNW4107, Imipenem/CilastatinDrug: XNW4107 100mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose | Drug | Cohort 5: End-stage renal disease (ESRD) receiving hemodialysis (HD) therapy |
Primary outcome
Total body clearance (CL) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Apparent steady-state volume of distribution (Vss) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Area under the curve from time zero to infinity (AUC0-∞)of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Maximum plasma concentration (Cmax) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
Time to the maximum plasma concentration (Tmax) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
The terminal elimination half-life (t1/2) of XNW4107, imipenem and cilastatin in subjects with various of Renal function.
Time frame: From baseline to 48 hours post-dose
1 secondary outcome
Adverse event (include SAEs) will be assessed and categorized.
Time frame: From baseline up to 10 days post-dose
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 16 Feb 2023.
- Derived from this study: PubMed 42657892Rodvold KA, Mamikonyan G, Wang Y, McRoberts A, Garg D, Preston R, Marabury T, Le M, Li J. Impact of renal impairment on pharmacokinetics, safety, and tolerability of funobactam, combined with imipenem and cilastatin. Antimicrob Agents Chemother. 2026 Aug 27:e0080826. doi: 10.1128/aac.00808-26. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
Jason Le study chair
Evopoint Biosciences Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XNW4107, Imipenem/Cilastatin in people with Bacterial Infections, run by Evopoint Biosciences Inc. at 2 sites in United States.
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 6 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Total body clearance (CL) of XNW4107, imipenem and cilastatin in subjects with various of Renal function. (time frame: From baseline to 48 hours post-dose). The study lists 6 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 NCT04787562, 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 16 Feb 2023.