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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03182504
Other study ID # NP39750
Secondary ID 2016-004478-16
Status Completed
Phase Phase 1
First received June 7, 2017
Last updated April 20, 2018
Start date June 15, 2017
Est. completion date August 10, 2017

Study information

Verified date April 2018
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
nacubactam
Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.
meropenem
Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.

Locations

Country Name City State
United States Pulmonary Associates Clinical Trials (PACT) Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary Maximum Concentration (Cmax) of Nacubactam in ELF At 2, 3, 4, 6 and 8 hours after study drug administration
Secondary 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
Secondary 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
Secondary 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
Secondary Clearance (CL) of Nacubactam At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Secondary 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
Secondary 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
Secondary 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
Secondary Maximum Concentration (Cmax) of Meropenem in ELF At 2, 3, 4, 6 and 8 hours after study drug administration
Secondary 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
Secondary 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
Secondary 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
Secondary Clearance (CL) of Meropenem At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Secondary 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
Secondary 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
Secondary 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
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