Healthy VolunteerPhase 1NCT06733675
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
A Phase 1 study testing Ledaborbactam etzadroxil, Ceftibuten and Ceftibuten-ledaborbactam etzadroxil in people with Healthy Volunteer and Pharmacokinetics, run by Basilea Pharmaceutica at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Pharmacokinetics, Safety
- What is being tested?
- Ledaborbactam etzadroxil, Ceftibuten and Ceftibuten-ledaborbactam etzadroxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to 30 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ICON, Clinical Research Phase I Unit
Lenexa, Kansas, 66219
Daniel Dickerson, MD. PhD, FAAFP, 913-205-4397, Daniel.Dickerson@iconplc.com
Daniel Dickerson, MD, PhD, FAAFP
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil
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.
- Conditions
- Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI), FDC
- Being tested
- Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil, Esomeprazole, amoxicillin-clavulanate
- Keywords
- Healthy Volunteers, Ceftibuten, Ledaborbactam etzadroxil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ledaborbactam etzadroxilDrug
capsules
CeftibutenDrug
capsules
Ceftibuten-ledaborbactam etzadroxilDrug
Fixed Dose Combination (FDC)
EsomeprazoleDrug
40 mg capsule
amoxicillin-clavulanateDrug
500 mg-125 mg oral doses
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 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 Receives: Drug: Ledaborbactam etzadroxil; Drug: Ceftibuten; Drug: Ceftibuten-ledaborbactam etzadroxil; Drug: Esomeprazole |
| Part 2 Group 1 | Experimental | Part 2 Group 1 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fasted Group) Receives: Drug: Ceftibuten-ledaborbactam etzadroxil |
| Part 2 Group 2 | Experimental | Part 2 Group 2 will enroll 10 participants. Each will receive oral doses of Ceftibuten-ledaborbactam etzadroxil FDC capsules for 7 days (Fed Group) Receives: Drug: Ceftibuten-ledaborbactam etzadroxil |
| Part 3 (Groups 1, 2, 4, 5, 6) | Experimental | 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 Receives: Drug: Ledaborbactam etzadroxil; Drug: Ceftibuten |
| Part 3 Group 3 | Active comparator | Part 3 Group 3 will enroll up to 10 participants. Each will receive oral doses of amoxicillin-clavulanate Receives: Drug: amoxicillin-clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Area under the concentration time curve from time zero to infinity (AUC0-∞)
Measured: 0 - 48 hours on days 1, 4 and 11
Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Maximum observed concentration (Cmax)
Measured: 0 - 48 hours on days 1, 4 and 11
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.
Measured: Day 1 thru Day 18 (+/-1)
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.
Measured: Day 1 thru Day 49 (± 2 days)
Secondary outcomes (5)
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.
Measured: Day 1 thru Day 18 (+/-1)
Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Area under the concentration time curve from time zero to 12h (AUC0-12h)
Measured: Day 1 and Day 7
Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
Maximum observed concentration (Cmax)
Measured: Day 1 and Day 7
Part 3 Plasma PK AUC0-Tau (ceftibuten and/or ledaborbactam)
Area under the concentration time curve from time zero to Tau (AUC0-Tau)
Measured: At Day 1 and Day 7
Part 3 Plasma PK Cmax (ceftibuten and/or ledaborbactam)
Maximum observed concentration (Cmax)
Measured: At Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start7 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Kamal Hamed, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733675
- Sponsor's protocol ID
- VNRX-7145-106
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No