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VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877379
Recruitment Status : Completed
First Posted : May 7, 2021
Last Update Posted : June 15, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Venatorx Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: VNRX-7145 Drug: VNRX-5024 (ceftibuten) Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part 1: Crossover Parts 2&3: Parallel
Masking: Double (Participant, Investigator)
Masking Description: Part 1: Unblinded Parts 2&3: Blinded
Primary Purpose: Basic Science
Official Title: VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers
Actual Study Start Date : June 8, 2021
Actual Primary Completion Date : November 10, 2021
Actual Study Completion Date : November 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1
Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.
 Drug: VNRX-7145
β-lactamase inhibitor

Drug: VNRX-5024 (ceftibuten)
β-lactam antibiotic
Experimental: Part 2A
Multiple dose administration of VNRX-7145 q8h for 10 days
 Drug: VNRX-7145
β-lactamase inhibitor
Placebo Comparator: Part 2B
Multiple dose administration of placebo q8h for 10 days
 Drug: Placebo
Placebo
Experimental: Part 3A
Multiple dose administration of low dose VNRX-7145 + VNRX-5024
 Drug: VNRX-7145
β-lactamase inhibitor

Drug: VNRX-5024 (ceftibuten)
β-lactam antibiotic
Experimental: Part 3B
Multiple dose administration of high dose VNRX-7145 + VNRX-5024
 Drug: VNRX-7145
β-lactamase inhibitor

Drug: VNRX-5024 (ceftibuten)
β-lactam antibiotic
Placebo Comparator: Part 3C
Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Cmax [ Time Frame: 0-48 hours ]
    concentration time data

  2. Part 1: AUC0-inf [ Time Frame: 0-48 hours ]
    Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK

  3. Parts 2&3: Number of subjects with adverse events [ Time Frame: Day 15 (+2) ]

Secondary Outcome Measures :
  1. Part 1: Number of subjects with adverse events [ Time Frame: Day 14 (+2) ]
  2. Parts 2&3: AUC0-tau [ Time Frame: Day 1 ]
  3. Parts 2&3: AUC0-tau [ Time Frame: Day 10 ]
  4. Parts 2&3: Cmax [ Time Frame: Day 1 ]
  5. Parts 2&3: Cmax [ Time Frame: Day 10 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults 18-55 years
  2. Males or non-pregnant, non-lactating females
  3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
  4. Normal blood pressure
  5. Normal lab tests

Exclusion Criteria:

  1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
  2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
  3. Use of antacid medications
  4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
  5. Positive alcohol, drug, or tobacco use/test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877379


Locations
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Netherlands
PRA Health Sciences - Early Development Services
Groningen, Netherlands
Sponsors and Collaborators
Venatorx Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Responsible Party: Venatorx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04877379    
Other Study ID Numbers: VNRX-7145-102
272201600029C-P00007-9999-2 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ceftibuten
Anti-Bacterial Agents
Anti-Infective Agents