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Cephalosporin

VNRX-7145 for Pharmacokinetics

Phase 1

Waitlist Available

Research Sponsored by Venatorx Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

Awards & highlights

Study Summary

This trial will study the effects of a new drug on how well it is absorbed by the body. Up to 36 healthy adults will be given the drug in either a fasted or fed state. The study will look at how ceftibuten is metabolized into its active parent drug VNRX-5236.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC0-inf

AUC0-t

Cmax

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

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

Group II: Cohort 2Experimental Treatment2 Interventions

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.

Group III: Cohort 1Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VNRX-7145

2020

Completed Phase 1

~200

Ceftibuten

2022

Completed Phase 1

~60

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Venatorx Pharmaceuticals, Inc.Lead Sponsor

12 Previous Clinical Trials

1,422 Total Patients Enrolled

2 Trials studying Pharmacokinetics

65 Patients Enrolled for Pharmacokinetics

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,269 Previous Clinical Trials

5,481,445 Total Patients Enrolled

2 Trials studying Pharmacokinetics

69 Patients Enrolled for Pharmacokinetics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prerequisites for participating in this research study?

"To be eligible for this scientific investigation, participants must have appropriate pharmacokinetic levels and reside between the ages of 18 to 65. The study is recruiting a maximum of 36 people in total."

Answered by AI

Has the federal agency approved VNRX-7145 for general consumption?

"VNRX-7145 has not undergone extensive safety testing, thus it is assigned a low score of 1."

Answered by AI

Are there any age limits to participation in this research program?

"This trial's inclusion criteria necessitates that all participants are between 18 and 65 years old. Separate studies have been set up for those under 18, as well as those above the age of 65 - 29 such programs in total."

Answered by AI

Are there any available slots still open for the trial's participants?

"Data hosted on clinicaltrials.gov shows that this medical study, originally posted in September 2022 and last updated November of the same year, is not seeking enrolment at present. However, a total of 39 other trials are currently accepting patients into their programs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

2022. "Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05527834.