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

Basilea Pharmaceutica

Status and phase: Enrolling; Phase 1

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

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

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, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). 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 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 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. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.

Enrollment: 96 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)

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96 participants in 5 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 (FDC) capsules; (c) Ceftibuten-ledaborbactam etzadroxil as FDC capsules after 5 days of esomeprazole orally once daily

Treatment:

Drug: Esomeprazole

Drug: Ledaborbactam etzadroxil

Drug: Ceftibuten-ledaborbactam etzadroxil

Drug: Ceftibuten

Part 2 Group 1

Experimental group

Description:

Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group)

Treatment:

Drug: Ceftibuten-ledaborbactam etzadroxil

Part 2 Group 2

Experimental group

Description:

Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group)

Treatment:

Drug: Ceftibuten-ledaborbactam etzadroxil

Part 3 (Groups 1, 2, 4, 5, 6)

Experimental group

Description:

Part 3 will enroll up to 50 participants. Each will receive oral doses of ceftibuten and/or ledaborbactam etzadroxil capsules (combined as FDC when administered together) in fed conditions

Treatment:

Drug: Ledaborbactam etzadroxil

Drug: Ceftibuten

Part 3 Group 3

Active Comparator group

Description:

Part 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate

Treatment:

Drug: amoxicillin-clavulanate