VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2021-11-10

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part 1: Crossover Parts 2\&3: Parallel

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Part 1: Unblinded Parts 2\&3: Blinded

Study Groups

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Part 1

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.

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

β-lactamase inhibitor

VNRX-5024 (ceftibuten)

Intervention Type DRUG

β-lactam antibiotic

Part 2A

Multiple dose administration of VNRX-7145 q8h for 10 days

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

β-lactamase inhibitor

Part 2B

Multiple dose administration of placebo q8h for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Part 3A

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

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

β-lactamase inhibitor

VNRX-5024 (ceftibuten)

Intervention Type DRUG

β-lactam antibiotic

Part 3B

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

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

β-lactamase inhibitor

VNRX-5024 (ceftibuten)

Intervention Type DRUG

β-lactam antibiotic

Part 3C

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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VNRX-7145

β-lactamase inhibitor

Intervention Type DRUG

VNRX-5024 (ceftibuten)

β-lactam antibiotic

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes