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

Phase 1RecruitingNCT06733675

Basilea Pharmaceutica46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Pharmacokinetics Safety Drug-Drug Interaction (DDI)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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)

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

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