Drug-Drug Interaction (DDI), FDC, Healthy Volunteer, Pharmacokinetics, Safety
Conditions
Keywords
Healthy Volunteers, Ceftibuten, Ledaborbactam etzadroxil
Brief summary
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.
Interventions
capsules
DRUGCeftibuten
capsules
DRUGCeftibuten-ledaborbactam etzadroxil
Fixed Dose Combination (FDC)
DRUGEsomeprazole
40 mg capsule
500 mg-125 mg oral doses
Sponsors
Basilea Pharmaceutica
Biomedical Advanced Research and Development Authority
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) | 0 - 48 hours on days 1, 4 and 11 | Area under the concentration time curve from time zero to infinity (AUC0-∞) |
| Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) | 0 - 48 hours on days 1, 4 and 11 | Maximum observed concentration (Cmax) |
| Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. | Day 1 thru Day 18 (+/-1) | Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. |
| Proportion of participants of Part 3 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. | Day 1 thru Day 49 (± 2 days) | Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. | Day 1 thru Day 18 (+/-1) | Participants experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation. |
| Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) | Day 1 and Day 7 | Area under the concentration time curve from time zero to 12h (AUC0-12h) |
| Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil) | Day 1 and Day 7 | Maximum observed concentration (Cmax) |
| Part 3 Plasma PK AUC0-Tau (ceftibuten and/or ledaborbactam) | At Day 1 and Day 7 | Area under the concentration time curve from time zero to Tau (AUC0-Tau) |
| Part 3 Plasma PK Cmax (ceftibuten and/or ledaborbactam) | At Day 1 and Day 7 | Maximum observed concentration (Cmax) |
Countries
United States
Contacts
CONTACTKarine Litherland, PhD
STUDY_DIRECTORKamal Hamed, MD
Basilea Pharmaceutica International Ltd, Allschwil
Outcome results
None listed