VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Bacterial Infections Clinical Trial

Official title:

VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332732
• Other study ID #: VNRX-5133-103
• Secondary ID: 272201300019C-3-
• Status: Completed
• Phase: Phase 1
• Start date: October 24, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: October 2018
• Source: VenatoRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy adults

• Males or non-pregnant, non-lactating females

• Body Mass Index (BMI) between 18.5 - 32.0, inclusive

• Weight greater than or equal to 50 kg

• Suitable veins for cannulation

Exclusion Criteria:

• Employee of site or the sponsor

• Any disease that poses an unacceptable risk to participants

• Abnormal ECG

• Abnormal labs

• Abnormal vital signs

• Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder

• Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• VNRX-5133
ß-lactamase inhibitor
• VNRX-5022
Approved ß-lactam antibiotic
• Metronidazole
Approved antibiotic and antiprotozoal medication
• Placebo
Placebo (matching VNRX-5133 + VNRX-5022)

Locations

Country	Name	City	State
United States	PRAHS	Lenexa	Kansas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bactericidal titers (Part 2)	To evaluate serum and urine bactericidal activity at peak and trough concentrations following multiple dose administration of VNRX-5133 + VNRX-5022	10 days
Primary	Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)	Cmax	0-48 hours
Primary	Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)	AUCinf	0-48 hours
Secondary	Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)	Cmax	0-48 hours
Secondary	Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)	AUCinf	0-48 hours
Secondary	Number of Subjects with Treatment Emergent Adverse Events	TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.	First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days
Secondary	Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration	Trough concentration levels from Day 1 - Day 10	Part 2: 10 days