VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

Healthy Subjects Clinical Trial

Official title:

VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877379
• Other study ID #: VNRX-7145-102
• Secondary ID: 272201600029C-P0
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: June 2022
• Source: Venatorx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 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): =18.5 kg/m2 and =32.0 kg/m2

4. Normal blood pressure

5. Normal lab tests

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. Use of antacid medications

4. Abnormal ECG or history of clinically significant abnormal rhythm disorder

5. Positive alcohol, drug, or tobacco use/test

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• VNRX-7145
ß-lactamase inhibitor
• VNRX-5024 (ceftibuten)
ß-lactam antibiotic
• Placebo
Placebo

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences - Early Development Services	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Venatorx Pharmaceuticals, Inc.	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Cmax	concentration time data	0-48 hours
Primary	Part 1: AUC0-inf	Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK	0-48 hours
Primary	Parts 2&3: Number of subjects with adverse events		Day 15 (+2)
Secondary	Part 1: Number of subjects with adverse events		Day 14 (+2)
Secondary	Parts 2&3: AUC0-tau		Day 1
Secondary	Parts 2&3: AUC0-tau		Day 10
Secondary	Parts 2&3: Cmax		Day 1
Secondary	Parts 2&3: Cmax		Day 10