Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteer; Pharmacokinetics; Safety; Drug-Drug Interaction (DDI); FDC
• Interventions: Drug: Ceftibuten-ledaborbactam etzadroxil

• Registration Number: NCT06733675
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief Summary

This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Study Start: 2025-01-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-08-13
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Healthy adult male or female, between 18 and 55 years of age
• Body mass index ≥ 18 and ≤ 32 kg/m2
• Laboratory values meeting defined laboratory ranges
• Males or non-pregnant, non-lactating females

Exclusion Criteria

• History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
• Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant
• Positive alcohol, drug or tobacco use/test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2 Group 2	Ceftibuten-ledaborbactam etzadroxil	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)

Primary Outcome Measures

Name	Time	Method
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)	0 - 48 hours on days 1, 4 and 11	Area under the concentration time curve from time zero to infinity (AUC0-∞)
Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)	0 - 48 hours on days 1, 4 and 11	Maximum observed concentration (Cmax)
Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.	Day 1 thru Day 18 (+/-1)	Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.	Day 1 thru Day 18 (+/-1)	Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)	Day 1 and Day 7	Area under the concentration time curve from time zero to 12h (AUC0-12h)
Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)	Day 1 and Day 7	Maximum observed concentration (Cmax)

Trial Locations

Locations (1)

ICON, Clinical Research Phase I Unit; 🇺🇸 Lenexa, Kansas, United States