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NCT04951505 Clinical Trial

Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04951505
Other study ID # VNRX-5133-107
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 29, 2021
Est. completion date September 27, 2021

Study information
Verified date September 2021
Source Venatorx Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 27, 2021
Est. primary completion date September 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Healthy adults 18-55 years 2. Males or non-pregnant, non-lactating females 3. Body mass index (BMI): =18 kg/m2 and =32.0 kg/m2, weight >50.0 kg. 4. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study 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. Recent history of known or suspected Clostridioides difficile infection 4. Abnormal ECG or history of clinically significant abnormal rhythm disorder 5. Abnormal lab tests

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• cefepime-taniborbactam
IV infusion

Locations
Country Name City State
United States Pulmonary Associates PA Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Venatorx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary ELF Cmax Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF) 0-8 hours after 6th dose
Secondary Number of subjects with adverse events Day 1 - Day 8
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