Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: VNRX-7145; Drug: Ceftibuten

• Registration Number: NCT05527834
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Study Start: 2022-09-13
• Primary Completion: 2023-02-06
• Study Completion: 2023-02-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	VNRX-7145	Cohort 1 will assess the impact of a high fat meal.
Cohort 3	Ceftibuten	Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.
Cohort 2	VNRX-7145	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.
Cohort 3	VNRX-7145	Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.
Cohort 1	Ceftibuten	Cohort 1 will assess the impact of a high fat meal.
Cohort 2	Ceftibuten	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

ICON Plc.; 🇺🇸 Lenexa, Kansas, United States