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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, 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.

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

  • amoxicillin-clavulanate

    Drug

    500 mg-125 mg oral doses

Treatment groups

96 Participants
are divided into 5 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 3 (Groups 1, 2, 4, 5, 6)Experimental treatment 2 interventions
Group E: Part 3 Group 3Active comparator 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)
4

Proportion of participants of Part 3 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 49 (± 2 days)

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
4

Part 3 Plasma PK AUC0-Tau (ceftibuten and/or ledaborbactam)

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

Time frame
At Day 1 and Day 7

Other outcomes

Sponsors and contacts

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Basilea Pharmaceutica

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
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