Bacterial InfectionsPhase 1NCT03332732
VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
A Phase 1 study testing VNRX-5133, VNRX-5022 and Metronidazole in people with Bacterial Infections, run by Venatorx Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- VNRX-5133, VNRX-5022 and Metronidazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2017to 20 Dec 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Males or non-pregnant, non-lactating females
- Body Mass Index (BMI) between 18.5 - 32.0, inclusive
- Weight greater than or equal to 50 kg
- Suitable veins for cannulation
Who cannot join
- Employee of site or the sponsor
- Any disease that poses an unacceptable risk to participants
- Abnormal ECG
- Abnormal labs
- Abnormal vital signs
- Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
- Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers
This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
- Conditions
- Bacterial Infections
- Being tested
- VNRX-5133, VNRX-5022, Metronidazole, Placebo
- Keywords
- Healthy Volunteers, Pharmacokinetics
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNRX-5133Drug
β-lactamase inhibitor
VNRX-5022Drug
Approved β-lactam antibiotic
MetronidazoleDrug
Approved antibiotic and antiprotozoal medication
PlaceboDrug
Placebo (matching VNRX-5133 + VNRX-5022)
| Study group | Role | What they receive |
|---|---|---|
| Part 1A | Experimental | In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule.. Receives: Drug: VNRX-5133; Drug: VNRX-5022 |
| Part 1B | Experimental | In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule. Receives: Drug: VNRX-5133; Drug: VNRX-5022; Drug: Metronidazole |
| Part 2 - 2A | Experimental | Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022 Receives: Drug: VNRX-5133; Drug: VNRX-5022 |
| Part 2 - 2B | Experimental | Multiple dose administration of High Dose VNRX-5133 + VNRX-5022 Receives: Drug: VNRX-5133; Drug: VNRX-5022 |
| Part 2 - 2C | Placebo comparator | Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
Cmax
Measured: 0-48 hours
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
AUCinf
Measured: 0-48 hours
Secondary outcomes (4)
Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Cmax
Measured: 0-48 hours
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
AUCinf
Measured: 0-48 hours
Number of Subjects with Treatment Emergent Adverse Events
TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Measured: First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration
Trough concentration levels from Day 1 - Day 10
Measured: Part 2: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start24 Oct 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1: Cross-over Part 2: Parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332732
- Sponsor's protocol ID
- VNRX-5133-103
- Other IDs
- 272201300019C-3-0-1, 17-0068
- Status last verified
- Oct 2018
- First submitted
- 28 Sep 2017
- Last updated
- 18 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03332732
- Acronym / sponsor ID
- VNRX-5133-103
- Conditions
- Bacterial Infections
- Keywords
- Healthy Volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 6 Nov 2017 (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 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Part 1: Cross-over Part 2: Parallel
| Arm | Type | Receives |
|---|---|---|
| Part 1A | Experimental | Drug: VNRX-5133, Drug: VNRX-5022In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule.. |
| Part 1B | Experimental | Drug: VNRX-5133, Drug: VNRX-5022, Drug: MetronidazoleIn part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule. |
| Part 2 - 2A | Experimental | Drug: VNRX-5133, Drug: VNRX-5022Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022 |
| Part 2 - 2B | Experimental | Drug: VNRX-5133, Drug: VNRX-5022Multiple dose administration of High Dose VNRX-5133 + VNRX-5022 |
| Part 2 - 2C | Placebo comparator | Drug: PlaceboMultiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults
- Males or non-pregnant, non-lactating females
- Body Mass Index (BMI) between 18.5 - 32.0, inclusive
- Weight greater than or equal to 50 kg
- Suitable veins for cannulation
Key exclusion criteria (7 listed)
- Employee of site or the sponsor
- Any disease that poses an unacceptable risk to participants
- Abnormal ECG
- Abnormal labs
- Abnormal vital signs
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-5133β-lactamase inhibitor | Drug | Part 1A, Part 1B, Part 2 - 2A, Part 2 - 2B |
| VNRX-5022Approved β-lactam antibiotic | Drug | Part 1A, Part 1B, Part 2 - 2A, Part 2 - 2B |
| MetronidazoleApproved antibiotic and antiprotozoal medication | Drug | Part 1B |
| PlaceboPlacebo (matching VNRX-5133 + VNRX-5022) | Drug | Part 2 - 2C |
Primary outcome
Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
Time frame: 0-48 hours
Cmax
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
Time frame: 0-48 hours
AUCinf
4 secondary outcomes
Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Time frame: 0-48 hours
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Time frame: 0-48 hours
Number of Subjects with Treatment Emergent Adverse Events
Time frame: First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration
Time frame: Part 2: 10 days
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 18 Oct 2018.
- 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.
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 VNRX-5133, VNRX-5022 and Metronidazole in people with Bacterial Infections, run by Venatorx Pharmaceuticals, Inc. at 1 site 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 5 inclusion and 7 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 18 Oct 2018. 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 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. Some participants in this study may receive a placebo. 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) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A) (time frame: 0-48 hours). The study lists 2 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 18 Oct 2018.