Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Study Overview
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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.

Official Title
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VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: VNRX-7145
* Drug: Ceftibuten


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Cohort 1 will assess the impact of a high fat meal. | Drug: VNRX-7145<br>* Single oral dose<br>Drug: Ceftibuten<br>* Single oral dose<br>|
| Experimental: Cohort 2<br>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. | Drug: VNRX-7145<br>* Single oral dose<br>Drug: Ceftibuten<br>* Single oral dose<br>|
| Experimental: Cohort 3<br>Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure. | Drug: VNRX-7145<br>* Single oral dose<br>Drug: Ceftibuten<br>* Single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed plasma concentration (Cmax) | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects | 
| AUC0-t | Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t) | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects | 
| AUC0-inf | AUC from time 0 extrapolated to infinity (AUC0-inf) | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects |