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

Venatorx Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteer; FDC; Drug-Drug Interaction (DDI); Safety; Pharmacokinetics

Treatments: Drug: Esomeprazole; Drug: Ledaborbactam etzadroxil; Drug: Ceftibuten; Drug: Ceftibuten-ledaborbactam etzadroxil

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06733675

VNRX-7145-106

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 4 patient groups

Part 1

Experimental group

Description:

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

Part 2 Group 1

Experimental group

Description:

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)

Part 2 Group 2

Experimental group

Description:

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)

Treatment:

Drug: Ceftibuten-ledaborbactam etzadroxil

Part 2 Group 3

Experimental group

Description:

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