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
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Subjects

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