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Completed

NCT Number: NCT04877379

VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Early Development Services

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VNRX-7145

Drug

β-lactamase inhibitor

VNRX-5024 (ceftibuten)

Drug

β-lactam antibiotic

Placebo

Drug

Placebo

Primary outcomes

  1. Part 1: Cmax

    Time frame: 0-48 hours

    concentration time data

  2. Part 1: AUC0-inf

    Time frame: 0-48 hours

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

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

    Time frame: Day 15 (+2)

Secondary outcomes

  1. Part 1: Number of subjects with adverse events

    Time frame: Day 14 (+2)

  2. Parts 2&3: AUC0-tau

    Time frame: Day 1

  3. Parts 2&3: AUC0-tau

    Time frame: Day 10

  4. Parts 2&3: Cmax

    Time frame: Day 1

  5. Parts 2&3: Cmax

    Time frame: Day 10

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 7, 2021
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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