Group 3 - Moderate Renal Impairment for Pharmacokinetics

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nucleus Network, Saint Paul, MN
Pharmacokinetics
VNRX-7145 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pharmacokinetics

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 0-120 hours post dose

0-120 hours post dose
AUC0-inf
Cmax
8 days post dose
Number of subjects with adverse events

Trial Safety

Safety Progress

1 of 3

Other trials for Pharmacokinetics

Trial Design

5 Treatment Groups

Group 3 - Moderate Renal Impairment
1 of 5
Group 1 - Control
1 of 5
Group 2 - Mild Renal Impairment
1 of 5
Group 4 - Severe Renal Impairment
1 of 5
Group 5 - End Stage Renal Disease
1 of 5
Experimental Treatment

32 Total Participants · 5 Treatment Groups

Primary Treatment: Group 3 - Moderate Renal Impairment · No Placebo Group · Phase 1

Group 3 - Moderate Renal ImpairmentExperimental Group · 2 Interventions: VNRX-7145, Ceftibuten · Intervention Types: Drug, Drug
Group 1 - ControlExperimental Group · 2 Interventions: VNRX-7145, Ceftibuten · Intervention Types: Drug, Drug
Group 2 - Mild Renal ImpairmentExperimental Group · 2 Interventions: VNRX-7145, Ceftibuten · Intervention Types: Drug, Drug
Group 4 - Severe Renal ImpairmentExperimental Group · 2 Interventions: VNRX-7145, Ceftibuten · Intervention Types: Drug, Drug
Group 5 - End Stage Renal DiseaseExperimental Group · 2 Interventions: VNRX-7145, Ceftibuten · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VNRX-7145
2020
Completed Phase 1
~140

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-120 hours post dose
Closest Location: Nucleus Network · Saint Paul, MN
2008First Recorded Clinical Trial
3 TrialsResearching Pharmacokinetics
69 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a healthy adult.
You are male or non-pregnant, non-lactating female.
You have a body mass index (BMI) of 18.5 or more and less than 40.0.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.