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Combination Therapy
Ceftibuten-ledaborbactam Etzadroxil for Healthy Subjects
Lenexa, KS
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
Healthy adult male or female, between 18 and 55 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 - 48 hours on days 1, 4 and 11
Awards & highlights
No Placebo-Only Group
Summary
This trial is a Phase 1 study involving around 46 healthy adults aged between 18 and 55. It will be conducted in two parts, with at least 16 participants in Part 1
See full description
Who is the study for?
This trial is for healthy adults aged 18-55 with a BMI between 18 and 32 kg/m2. Participants must have lab values within specific ranges and cannot be pregnant or breastfeeding. The study excludes anyone not meeting these health criteria.Check my eligibility
What is being tested?
The study tests a fixed-dose combination of Ceftibuten-ledaborbactam etzadroxil, comparing it to Ledaborbactam etzadroxil, Ceftibuten, and Esomeprazole alone. It's designed to assess safety and how the body processes these drugs in two parts over roughly six weeks.See study design
What are the potential side effects?
As this is a Phase 1 trial primarily focused on safety and pharmacokinetics (how the drug is processed by the body), potential side effects are monitored closely but may include typical drug reactions such as gastrointestinal discomfort, headaches, or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult aged between 18 and 55.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 - 48 hours on days 1, 4 and 11
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 - 48 hours on days 1, 4 and 11
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Secondary study objectives
Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2 Group 3Experimental Treatment1 Intervention
Part 2 Group 3 will possibly enroll 10 participants. Following availability of PK and safety data from Groups 1 and 2, a determination will be made regarding whether or not Group 3 is needed and the dosing conditions that apply
Group II: Part 2 Group 2Experimental Treatment1 Intervention
Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days (Fed Group)
Group III: Part 2 Group 1Experimental Treatment1 Intervention
Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil as fixed-dose capsules for 7 days (Fasted Group)
Group IV: Part 1Experimental Treatment4 Interventions
Part 1 will enroll at least 16 participants who will receive a single oral dose of ceftibuten and ledaborbactam etzadroxil following a 10-hour fast on 3 occasions in a fixed sequence: (a) Ceftibuten and ledaborbactam etzadroxil as separate capsules; (b) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination capsules; (c) Ceftibuten-ledaborbactam etzadroxil as fixed-dose combination capsules after 5 days of esomeprazole orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftibuten
2024
Completed Phase 1
~70
Esomeprazole
2008
Completed Phase 4
~2670
Find a Location
Closest Location:ICON, Clinical Research Phase I Unit· Lenexa, KS· 188 miles
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Venatorx Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
1,477 Total Patients Enrolled
Biomedical Advanced Research and Development AuthorityFED
106 Previous Clinical Trials
575,077 Total Patients Enrolled
Fernando de Oliveira, MD, PhD, MSStudy DirectorVenatorx Pharmaceuticals
1 Previous Clinical Trials
31 Total Patients Enrolled