Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Pharmacokinetics Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527834
• Other study ID #: VNRX-7145-104
• Secondary ID: 272201600029C-P0
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: July 2023
• Source: Venatorx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 10, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• VNRX-7145
Single oral dose
• Ceftibuten
Single oral dose

Locations

Country	Name	City	State
United States	ICON Plc.	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Venatorx Pharmaceuticals, Inc.	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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