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

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Basilea Pharmaceutica
Study ID
NCT06733675
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ledaborbactam etzadroxil — DRUG
    capsules
  • Ceftibuten — DRUG
    capsules
  • Ceftibuten-ledaborbactam etzadroxil — DRUG
    Fixed Dose Combination (FDC)
  • Esomeprazole — DRUG
    40 mg capsule
  • amoxicillin-clavulanate — DRUG
    500 mg-125 mg oral doses

Study Details

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.

Key Dates

First listed
Dec 13, 2024
Start date
Jan 7, 2025
Status verified
Jul 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 (FDC) capsules; (c) Ceftibuten-ledaborbactam etzadroxil as FDC capsules after 5 days of esomeprazole orally once daily
  • Experimental: Part 2 Group 1
    Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group)
  • Experimental: Part 2 Group 2
    Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group)
  • Experimental: Part 3 (Groups 1, 2, 4, 5, 6)
    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
  • Active Comparator: Part 3 Group 3
    Part 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate

Primary Outcome Measure

Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) [ Time Frame: 0 - 48 hours on days 1, 4 and 11 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICON, Clinical Research Phase I UnitLenexaKansas66219
Daniel Dickerson, MD. PhD, FAAFP
[email protected]
913-205-4397
Daniel Dickerson, MD, PhD, FAAFP (PRINCIPAL_INVESTIGATOR)

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By research site
ICON, Clinical Research Phase I Unit· Lenexa, KS

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