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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is a Phase 1, open-label, single-center PK study in healthy adult male and female participants between 18 and 55 years of age (both inclusive). Thirty-one participants will each undergo one standard bronchoscopy with bronchoalveolar lavage (BAL) following the fifth dose of ceftibuten-ledaborbactam etzadroxil or ceftibuten alone. BAL fluid samples and plasma samples will be collected at designated timepoints to determine the concentrations of ceftibuten, ledaborbactam, and urea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants in Group 1 will undergo one standardized bronchoscopy with bronchoalveolar lavage after the fifth dose of ceftibuten-ledaborbactam etzadroxil. |
|
| Group 2 | Experimental | Participants in Group 2 will undergo one standardized bronchoscopy with bronchoalveolar lavage after the fifth of dose of ceftibuten alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ledaborbactam etzadroxil | Drug | Five doses of ledaborbactam etzadroxil will be administered orally every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intrapulmonary PK - AUC0-12 (ceftibuten) | Area under the curve from time zero to 12 hours | 0-12 hours after 5th dose |
| Intrapulmonary PK - AUC0-12 (ledaborbactam) | Area under the curve from time zero to 12 hours | 0-12 hours after 5th dose |
| Plasma PK - Cmax (ceftibuten) | Maximum concentration | 0-12 hours after 5th dose |
| Plasma PK - Cmax (ledaborbactam) | Maximum concentration | 0-12 hours after 5th dose |
| Plasma PK - AUC0-12 (ceftibuten) | Area under the curve from time zero to 12 hours | Time Frame: 0-12 hours after 5th dose |
| Plasma PK - AUC0-12 (ledaborbactam) | Area under the curve from time zero to 12 hours | 0-12 hours after 5th dose |
| Ratios of drug exposure in ELF to plasma using the AUC values for each matrix | 0-12 hours after 5th dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Day 1 - Day 8 | |
| Proportion of participants discontinuing study drug due to TEAEs and SAEs | Day 1 - Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Hamed, MD | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008649 | Derived | Rodvold KA, Gotfried MH, de Oliveira CF, Lowe K, Hamed KA, Litherland K, Engelhardt M, McGovern PC. Plasma and intrapulmonary pharmacokinetics of ceftibuten and ledaborbactam in healthy male and female adults. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0195025. doi: 10.1128/aac.01950-25. Epub 2026 Apr 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 13, 2026 | |
| Reset | Mar 31, 2026 | |
| Release | Apr 14, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2024 | Jan 21, 2026 |
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| ceftibuten | Drug | Five doses of ceftibuten will be administered orally every 12 hours |
|
| Reset | May 4, 2026 |
| Release | May 15, 2026 |
| Unrelease | May 18, 2026 |
| Release | May 21, 2026 |
| Reset | Jun 17, 2026 |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 13, 2026 | Mar 31, 2026 | |||
| Apr 14, 2026 | May 4, 2026 | |||
| May 15, 2026 | May 18, 2026 | |||
| May 21, 2026 | Jun 17, 2026 | |||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D000077722 | Ceftibuten |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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