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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

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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 - 48 hours on days 1, 4 and 11 for reporting.

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