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

NCT ID: NCT06733675

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Healthy Volunteer Pharmacokinetics Safety Drug-Drug Interaction (DDI) FDC

Keywords

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Healthy Volunteers Ceftibuten Ledaborbactam etzadroxil

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

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

Group Type EXPERIMENTAL

Ledaborbactam etzadroxil

Intervention Type DRUG

capsules

Ceftibuten

Intervention Type DRUG

capsules

Ceftibuten-ledaborbactam etzadroxil

Intervention Type DRUG

Fixed Dose Combination (FDC)

Esomeprazole

Intervention Type DRUG

40 mg capsule

Part 2 Group 1

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 Type EXPERIMENTAL

Ceftibuten-ledaborbactam etzadroxil

Intervention Type DRUG

Fixed Dose Combination (FDC)

Part 2 Group 2

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 Type EXPERIMENTAL

Ceftibuten-ledaborbactam etzadroxil

Intervention Type DRUG

Fixed Dose Combination (FDC)

Part 2 Group 3

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 Type EXPERIMENTAL

Ceftibuten-ledaborbactam etzadroxil

Intervention Type DRUG

Fixed Dose Combination (FDC)

Interventions

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Ledaborbactam etzadroxil

capsules

Intervention Type DRUG

Ceftibuten

capsules

Intervention Type DRUG

Ceftibuten-ledaborbactam etzadroxil

Fixed Dose Combination (FDC)

Intervention Type DRUG

Esomeprazole

40 mg capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kamal Hamed, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd, Allschwil

Locations

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ICON, Clinical Research Phase I Unit

Lenexa, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karine Litherland, PhD

Role: CONTACT

Phone: +41616061111

Email: [email protected]

Facility Contacts

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Daniel Dickerson, MD. PhD, FAAFP

Role: primary

Other Identifiers

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VNRX-7145-106

Identifier Type: -

Identifier Source: org_study_id