Clinical trial NCT06733675: Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Pharmacokinetics
Safety
Drug-Drug Interaction (DDI)
FDC
Keywords: Healthy Volunteers
Ceftibuten
Ledaborbactam etzadroxil
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2024-12-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Part 1 Plasma PK AUC0-∞ (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
timeFrame: 0 - 48 hours on days 1, 4 and 11
measure: Part 1 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
timeFrame: 0 - 48 hours on days 1, 4 and 11
measure: Proportion of participants of Part 2 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
timeFrame: Day 1 thru Day 18 (+/-1)
Secondary outcomes:
measure: Proportion of participants of Part 1 experiencing Treatment-emergent adverse events (TEAEs), Serious TEAEs, or TEAEs leading to discontinuation.
timeFrame: Day 1 thru Day 18 (+/-1)
measure: Part 2 Plasma PK AUC0-12h (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
timeFrame: Day 1 and Day 7
measure: Part 2 Plasma PK Cmax (ceftibuten, ledaborbactam, and ledaborbactam etzadroxil)
timeFrame: Day 1 and Day 7
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON, Clinical Research Phase I Unit
state: Kansas
Study officials:
affiliation: Venatorx Pharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: