Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: VNRX-7145; Drug: Ceftibuten

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05527834

272201600029C-P00017-9999-1 (U.S. NIH Grant/Contract)

VNRX-7145-104

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Ceftibuten

Drug: VNRX-7145

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Ceftibuten

Drug: VNRX-7145

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Ceftibuten

Drug: VNRX-7145