VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

NCT04877379 | Completed Phase 1

• 2 other identifiers: VNRX-7145-102272201600029C-P00007-9999-2
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Part 1: Cmax

  concentration time data

  0-48 hours

• Part 1: AUC0-inf

  Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK

  0-48 hours

• Parts 2&3: Number of subjects with adverse events

  Day 15 (+2)

Secondary Outcomes (5)

• Part 1: Number of subjects with adverse events

  Day 14 (+2)

• Parts 2&3: AUC0-tau

  Day 1

• Parts 2&3: AUC0-tau

  Day 10

• Parts 2&3: Cmax

  Day 1

• Parts 2&3: Cmax

  Day 10

Study Arms (6)

Part 1

EXPERIMENTAL

Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.

Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten)

Part 2A

EXPERIMENTAL

Multiple dose administration of VNRX-7145 q8h for 10 days

Drug: VNRX-7145

Part 2B

PLACEBO COMPARATOR

Multiple dose administration of placebo q8h for 10 days

Drug: Placebo

Part 3A

EXPERIMENTAL

Multiple dose administration of low dose VNRX-7145 + VNRX-5024

Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten)

Part 3B

EXPERIMENTAL

Multiple dose administration of high dose VNRX-7145 + VNRX-5024

Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten)

Part 3C

PLACEBO COMPARATOR

Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)

Drug: Placebo

Interventions

VNRX-7145 DRUG

β-lactamase inhibitor

Part 1; Part 2A; Part 3A; Part 3B

VNRX-5024 (ceftibuten) DRUG

β-lactam antibiotic

Part 1; Part 3A; Part 3B

Placebo DRUG

Placebo

Part 2B; Part 3C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults 18-55 years
• Males or non-pregnant, non-lactating females
• Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
• Normal blood pressure
• Normal lab tests

You may not qualify if:

• History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
• History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
• Use of antacid medications
• Abnormal ECG or history of clinically significant abnormal rhythm disorder
• Positive alcohol, drug, or tobacco use/test

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Basilea Pharmaceutica: lead

Study Sites (1)

PRA Health Sciences - Early Development Services

Groningen, Netherlands

Location

Related Publications (1)

• de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.

  PMID: 40762486 DERIVED

MeSH Terms

Interventions

Ceftibuten

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kamal Hamed, MD

  Basilea Pharmaceutica International Ltd, Allschwil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1: Unblinded Parts 2\&3: Blinded
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Crossover Parts 2\&3: Parallel

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: June 8, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

NL (1)