PharmacokineticsPhase 1NCT03690362
VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
A Phase 1 study testing VNRX-5133 and VNRX-5022 in people with Pharmacokinetics, run by Venatorx Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- VNRX-5133 and VNRX-5022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Apr 2018to 21 Nov 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI: 18.5-40.0 kg/m2 with a minimum weight of 45 kg
- Able and willing to abstain from alcohol from 48 h before admission until the follow-up visit
- Suitable veins for cannulation/multiple venipunctures, as assessed by the Investigator at Screening
- Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration.
- Laboratory values meeting defined entry criteria
- Subjects with normal renal function (Group 1) must also meet the following criteria:
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- Match to one or more subjects with renal impairment by gender, age, and weight
- Subjects with renal impairment (Groups 2-5) must also meet the following criteria:
- Stable, pre-existing renal impairment.
Who cannot join
- Employee of the study site, Contract Research Organization (CRO) or the IND Sponsor
- Female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
- Male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
- Use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent)
- The subject has a congenital or acquired immunodeficiency syndrome
- Screening or Day -1, clinically significant abnormal ECG values
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- Active malignancy; exceptions are permitted for carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted
- History of drug allergy of a severity that required urgent medical treatment, such as treatment with epinephrine in an Emergency Department
- Known immediate hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
- History of donation of more than 450 mL of blood within 60 days before dosing in the site or planned donation before 30 days has elapsed since ingestion of study drug
- Plasma or platelet donation within 7 days of dosing and throughout the study
- Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year
- Oral temperature >38.5˚C or acute illness on Day -1
- Previous participation in a study of VNRX-5133
- Excluded concomitant medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Orlando Cliniical Research Associates
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.
- Conditions
- Pharmacokinetics
- Being tested
- VNRX-5133 and VNRX-5022
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNRX-5133 and VNRX-5022Drug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control | Experimental | Healthy control subjects will be matched by gender, weight, and age to subjects with renal impairment Receives: Drug: VNRX-5133 and VNRX-5022 |
| Group 2 - Mild Renal Impairment | Experimental | Mild renal impairment Receives: Drug: VNRX-5133 and VNRX-5022 |
| Group 3 - Moderate Renal Impairment | Experimental | Moderate Renal Impairment Receives: Drug: VNRX-5133 and VNRX-5022 |
| Group 4 - Severe Renal Impairment | Experimental | Severe Renal Impairment Receives: Drug: VNRX-5133 and VNRX-5022 |
| Group 5 - ESRD | Experimental | End Stage Renal Disease undergoing chronic intermittent hemodialysis Receives: Drug: VNRX-5133 and VNRX-5022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of Cmax
Measured: 72 hours
Area under the plasma concentration versus time curve (AUC)
To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of AUC
Measured: 72 hours
Safety and tolerability of VNRX-5133 and VNRX-5022 measured as number of subjects with adverse events.
Number of Subjects with AEs (Assessed via patient report, physical exam, ECGs, vital signs, laboratory investigations, and use of concomitant medications for the treatment of AEs)
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start6 Apr 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
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 PharmacokineticsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The study will enroll approximately 32 subjects assigned to treatment groups based on renal function.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690362
- Sponsor's protocol ID
- VNRX-5133-104
- Other IDs
- 272201300019C-12-0-3, 17-0103
- Status last verified
- Feb 2019
- First submitted
- 21 Mar 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dowell JA, Marbury TC, Smith WB, Henkel T. Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment. Antimicrob Agents Chemother. 2022 Sep 20;66(9):e0025322. doi: 10.1128/aac.00253-22. Epub 2022 Aug 3.
PubMed 35920662
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT03690362
- Acronym / sponsor ID
- VNRX-5133-104
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 1 Oct 2018 (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 multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study will enroll approximately 32 subjects assigned to treatment groups based on renal function.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Control | Experimental | Drug: VNRX-5133 and VNRX-5022Healthy control subjects will be matched by gender, weight, and age to subjects with renal impairment |
| Group 2 - Mild Renal Impairment | Experimental | Drug: VNRX-5133 and VNRX-5022Mild renal impairment |
| Group 3 - Moderate Renal Impairment | Experimental | Drug: VNRX-5133 and VNRX-5022Moderate Renal Impairment |
| Group 4 - Severe Renal Impairment | Experimental | Drug: VNRX-5133 and VNRX-5022Severe Renal Impairment |
| Group 5 - ESRD | Experimental | Drug: VNRX-5133 and VNRX-5022End Stage Renal Disease undergoing chronic intermittent hemodialysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- BMI: 18.5-40.0 kg/m2 with a minimum weight of 45 kg
- Able and willing to abstain from alcohol from 48 h before admission until the follow-up visit
- Suitable veins for cannulation/multiple venipunctures, as assessed by the Investigator at Screening
- Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration.
- Laboratory values meeting defined entry criteria
Key exclusion criteria (15 listed)
- Employee of the study site, Contract Research Organization (CRO) or the IND Sponsor
- Female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
- Male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
- Use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent)
- The subject has a congenital or acquired immunodeficiency syndrome
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 |
|---|---|---|
| VNRX-5133 and VNRX-5022intravenous infusion | Drug | Group 1 - Control, Group 2 - Mild Renal Impairment, Group 3 - Moderate Renal Impairment, Group 4 - Severe Renal Impairment, Group 5 - ESRD |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 72 hours
To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of Cmax
Area under the plasma concentration versus time curve (AUC)
Time frame: 72 hours
To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of AUC
Safety and tolerability of VNRX-5133 and VNRX-5022 measured as number of subjects with adverse events.
Time frame: 8 Days
Number of Subjects with AEs (Assessed via patient report, physical exam, ECGs, vital signs, laboratory investigations, and use of concomitant medications for the treatment of AEs)
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 8 Feb 2019.
- Derived from this study: PubMed 35920662Dowell JA, Marbury TC, Smith WB, Henkel T. Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment. Antimicrob Agents Chemother. 2022 Sep 20;66(9):e0025322. doi: 10.1128/aac.00253-22. Epub 2022 Aug 3.
- Individual participant dataSharing planned: No
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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.
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 VNRX-5133 and VNRX-5022 in people with Pharmacokinetics, run by Venatorx Pharmaceuticals, 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 9 inclusion and 15 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 8 Feb 2019. 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?
Peak Plasma Concentration (Cmax) (time frame: 72 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?
On the ClinicalTrials.gov record for NCT03690362, 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 8 Feb 2019.