Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: cefepime-taniborbactam

• Registration Number: NCT04951505
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-06-28
• Study Start: 2021-06-29
• Study First Posted: 2021-07-06
• Status Verified: 2021-09
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cefepime-taniborbactam	cefepime-taniborbactam	-

Primary Outcome Measures

Name	Time	Method
ELF Cmax	0-8 hours after 6th dose	Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Day 1 - Day 8

Trial Locations

Locations (1)

Pulmonary Associates PA; 🇺🇸 Phoenix, Arizona, United States