Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

• Sponsor: Venatorx Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04951505
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: cefepime-taniborbactam	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
• Actual Study Start Date: Jun 29, 2021
• Actual Primary Completion Date: Sep 27, 2021
• Actual Study Completion Date: Sep 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cefepime-taniborbactam	Drug: cefepime-taniborbactam; IV infusion

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of subjects with adverse events [Day 1 - Day 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Associates PA	Phoenix	Arizona	United States	85032

Sponsors and Collaborators

• Venatorx Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Venatorx Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04951505
• Other Study ID Numbers: VNRX-5133-107
• First Posted: Jul 6, 2021
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cefepime

Study Results

No Results Posted as of Oct 1, 2021