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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Enrollment target: 46 to 96v10 Show 5 more changesShow less
    • Primary and study completion dates: Jun 30, 2026 to Dec 30, 2026
    • Primary endpoints: 3 to 4
    • Interventions: Ceftibuten (Drug), Ceftibuten-ledaborbactam etzadroxil (Drug), Esomeprazole (Drug), Ledaborbactam etzadroxil (Drug) to Ceftibuten (Drug), Ceftibuten-ledaborbactam etzadroxil (Drug), Esomeprazole (Drug), Ledaborbactam etzadroxil (Drug)…
    • Secondary endpoints: 3 to 5
    • Study arms: 4 to 5
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v9
  3. Lead sponsor: Venatorx Pharmaceuticals, Inc. to Basilea Pharmaceuticav8
  4. Primary completion date: Aug 13, 2025 to Jun 30, 2026
    • Study completion date: Sep 15, 2025 to Jun 30, 2026
    v7
  5. Re-verified, no change to tracked fieldsv6
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  1. Primary completion date: Mar 7, 2025 to Aug 13, 2025
    • Study completion date: May 10, 2025 to Sep 15, 2025
    v5
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study completion date: Sep 10, 2025 to May 10, 2025
    v3
  4. Primary endpoints revised (3)
    • Secondary endpoints revised (3)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06733675
Lead Sponsor Basilea Pharmaceutica
Collaborators: Biomedical Advanced Research and Development Authority
Conditions
(from sponsor)		 Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov