Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004478-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. Adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nacubactam Plus Meropenem | Experimental | Participants will receive a single dose of nacubactam co-administered with meropenem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nacubactam | Drug | Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio | The ELF to plasma ratio will be calculated from the concentration of nacubactam in ELF and plasma as a measure of the intrapulmonary penetration of nacubactam in healthy participants. | At 2, 3, 4, 6 and 8 hours after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| ELF Concentration of Meropenem to Plasma Concentration of Meropenem Ratio | The ELF to plasma ratio will be calculated from the concentration of meropenem in ELF and plasma as a measure of the intrapulmonary penetration of meropenem in healthy participants.. | At 2, 3, 4, 6 and 8 hours after study drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates Clinical Trials (PACT) | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42059802 | Derived | Morita J, Ishiwata K, Matsumoto S, Kato S, Attley G, Patel K, Rodriguez I, Mallalieu NL. Evidence of intrapulmonary penetration of nacubactam, a novel beta-lactamase inhibitor, following coadministration of nacubactam with meropenem in healthy adults. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0002626. doi: 10.1128/aac.00026-26. Epub 2026 Apr 30. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608518 | nacubactam |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| meropenem | Drug | Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours. |
|
|
| Area Under the Plasma Concentration-Time Curve from time 0 to 8 hours (AUC0-8) of Nacubactam in ELF |
| At 2, 3, 4, 6 and 8 hours after study drug administration |
| Maximum Concentration (Cmax) of Nacubactam in ELF | At 2, 3, 4, 6 and 8 hours after study drug administration |
| Area Under the Plasma Concentration-Time Curve from Time 0 to 8 Hours (AUC0-8) of Nacubactam in Blood Plasma | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Maximum Concentration (Cmax) of Nacubactam in Blood Plasma | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Time to Reach the Maximum Plasma Concentration (Tmax) of Nacubactam | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Clearance (CL) of Nacubactam | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Volume of Distribution of the Central Compartment (Vc) of Nacubactam | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Volume of Distribution at Steady-State (Vss) of Nacubactam | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Area Under the Plasma Concentration-Time Curve from Time 0 to 8 Hours (AUC0-8) of Meropenem in ELF | At 2, 3, 4, 6 and 8 hours after study drug administration |
| Maximum Concentration (Cmax) of Meropenem in ELF | At 2, 3, 4, 6 and 8 hours after study drug administration |
| Area Under the Plasma Concentration-Time Curve from Time 0 to 8 hours (AUC0-8) of Meropenem in Blood Plasma | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Maximum Concentration (Cmax) of Meropenem in Blood Plasma | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Time to Reach the Maximum Plasma Concentration (Tmax) of Meropenem | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Clearance (CL) of Meropenem | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Volume of Distribution of the Central Compartment (Vc) of Meropenem | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Volume of Distribution at Steady-State (Vss) of Meropenem | At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration |
| Number of Participants with Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | From baseline up to 14 days after study drug administration |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |