Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: cefepime-taniborbactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04951505

VNRX-5133-107

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

cefepime-taniborbactam

Experimental group

Treatment:

Drug: cefepime-taniborbactam