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Trial record 3 of 79934 for:    subjects

Safety and Pharmacokinetics of VNRX-5133 in the Epithelial Lining Fluid of Healthy Adult Subjects

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: NCT03870490
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
VenatoRx Pharmaceuticals, Inc.

Brief Summary:
This is a single-center, open-label study to assess safety and pharmacokinetics of VNRX-5133 and cefepime in the epithelial lining fluid in healthy adult male and female subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: VNRX-5133 + cefepime Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Trial to Assess the Safety and Pharmacokinetics of VNRX-5133 in the Epithelial Lining Fluid of Healthy Adult Subjects
Actual Study Start Date : March 14, 2019
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy Subjects
VNRX-5133 + cefepime
Drug: VNRX-5133 + cefepime
IV infusion (3 doses)




Primary Outcome Measures :
  1. Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF) [ Time Frame: Day 2 ]
    Steady-state plasma PK and disposition of cefepime/VNRX-5133 in the ELF

  2. Safety as measured by the number of subjects with adverse events [ Time Frame: Days 1-7 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to participate in the trial, give written informed consent, and comply with the trial restrictions
  • Gender: male or female with a negative serum pregnancy test (β-human chorionic gonadotropin [β-hCG]) at Screening and Day -1; females may be of childbearing potential or of nonchildbearing potential
  • Age: ≥18 years at Screening
  • Weight: ≥50 kg
  • Body mass index (BMI): ≥18 kg/m2 and <30 kg/m2
  • Normal blood pressure (BP), defined as a systolic value ≥90 mm Hg and ≤140 mm Hg and a diastolic value <90 mm Hg (Screening and Day -1)
  • All values for hematology and clinical chemistry tests of blood and urine are either within normal limits of laboratory reporting range (WNL) or defined as permitted exceptions
  • Ability and willingness to abstain from alcohol, from 48 hours (2 days) prior to admission to the Clinical Research Center (CRC) until discharge from the CRC
  • Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during this trial and for 90 days after the last dose of study drug
  • All over-the-counter (OTC) medications, health supplements, and herbal remedies (eg, St. John's Wort extract) must have been stopped at least 14 days prior to admission to the CRC
  • Suitable veins for cannulation/multiple venipunctures as assessed by the Investigator at Screening

Exclusion Criteria:

  • Employee of the Contract Research Organization (CRO), CRC, or the Sponsor
  • Female who is pregnant, lactating, or at risk of becoming pregnant during this trial or within 90 days after the last dose of study drug
  • Male with a female partner who is pregnant or lactating during this trial or planning to attempt to become pregnant during this trial or within 90 days after the last dose of study drug
  • Use of any investigational drug or device within 30 days prior to Screening (90 days for an injectable biological agent)
  • Presence of a congenital or acquired immunodeficiency syndrome
  • Any evidence or history of clinically significant medical abnormalities on PE or laboratory assessment
  • Clinically significant ECG abnormality
  • Sitting systolic BP >140 mm Hg or diastolic BP >90 mm Hg on a single measurement following at least 5 minutes of rest at Screening
  • History of drug allergy of a severity that required urgent medical treatment such as treatment with epinephrine in an Emergency Department
  • History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug or any component of VNRX-5133 for injection formulation
  • History of hypersensitivity to lidocaine, midazolam, fentanyl, or other topical anesthetics/opioids in similar classes to these agents
  • Use of prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study drug
  • History of donation of >450 mL of blood within 60 days prior to first dose of study drug or planned donation before 30 days has elapsed since final dose of study drug
  • Plasma or platelet donation within 7 days of first dose of study drug or planned donation during this trial
  • Current suspected drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria
  • Recent history of alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 standard drink=5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months before Screening
  • Use of tobacco- or nicotine-containing products from Screening through Check Out

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): NCT03870490


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
VenatoRx Pharmaceuticals, Inc.
National Institutes of Health (NIH)

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Responsible Party: VenatoRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03870490     History of Changes
Other Study ID Numbers: VNRX-5133-106
272201300019C-17-0-3 ( U.S. NIH Grant/Contract )
18-0001 ( Other Identifier: DMID )
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cefepime
Anti-Bacterial Agents
Anti-Infective Agents