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

ConditionsHealthy VolunteerPharmacokineticsSafetyDrug-Drug Interaction (DDI)FDC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBasilea Pharmaceutica

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ledaborbactam etzadroxil

    Drug

    capsules

  • Ceftibuten

    Drug

    capsules

  • Ceftibuten-ledaborbactam etzadroxil

    Drug

    Fixed Dose Combination (FDC)

  • Esomeprazole

    Drug

    40 mg capsule

Treatment groups

46 Participants
are divided into 4 treatment groups
Group A: Part 1Experimental treatment 4 interventions
Group B: Part 2 Group 1Experimental treatment 1 intervention
Group C: Part 2 Group 2Experimental treatment 1 intervention
Group D: Part 2 Group 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)

Area under the concentration time curve from time zero to infinity (AUC0-∞)

Time frame
0 - 48 hours on days 1, 4 and 11
2

Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)

Maximum observed concentration (Cmax)

Time frame
0 - 48 hours on days 1, 4 and 11
3

Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.

Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.

Time frame
Day 1 thru Day 18 (+/-1)

Secondary outcomes

1

Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.

Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.

Time frame
Day 1 thru Day 18 (+/-1)
2

Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)

Area under the concentration time curve from time zero to 12h (AUC0-12h)

Time frame
Day 1 and Day 7
3

Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)

Maximum observed concentration (Cmax)

Time frame
Day 1 and Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Basilea Pharmaceutica

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
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