Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-02-10

Brief Summary

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This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.

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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Cohort 1 will assess the impact of a high fat meal.

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

Single oral dose

Ceftibuten

Intervention Type DRUG

Single oral dose

Cohort 2

Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure.

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

Single oral dose

Ceftibuten

Intervention Type DRUG

Single oral dose

Cohort 3

Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

Single oral dose

Ceftibuten

Intervention Type DRUG

Single oral dose

Interventions

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VNRX-7145

Single oral dose

Intervention Type DRUG

Ceftibuten

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults 18-65 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
* Laboratory values meeting defined entry criteria

Exclusion Criteria

* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug
* Conditions that potentially alter absorption and/or excretion of orally administered drugs
* Congenital or acquired immunodeficiency syndrome
* Positive alcohol, drug, or tobacco use/test

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes