A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants

Roche

Status and phase

Completed

Phase 1

Conditions

Gram-negative Bacterial Infections

Treatments

Drug: meropenem

Drug: nacubactam

Study type

Interventional

Funder types

Industry

Identifiers

NCT03182504

NP39750

2016-004478-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 to 60 years of age, inclusive
Healthy, as judged by the Investigator and defined by the absence of evidence of any active or clinically significant chronic disease identified from a detailed medical and surgical history, physical examination including vital signs and 12-lead electrocardiogram (ECG), and laboratory safety test results
Body mass index (BMI) within the range 18-30 kilogram per square meter (kg/m^2),inclusive
Non-smoker, or former smoker who has abstained from smoking for at least 6 months
Negative pregnancy test and agreement to comply with measures to prevent pregnancy in women
Refrain from sperm donation and agreement to comply with measures to prevent pregnancy in partner of childbearing potential for men

Exclusion criteria

History of asthma or clinically significant lung disease
Any condition which contraindicates a BAL procedure
History of clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, dermatological, immunological or allergic disease, metabolic disorder, cancer or cirrhosis
Clinically significant change in health status, as judged by the Investigator, or any major illness within the four weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders
Participation in any other clinical study involving an investigational medicinal product or device within 3 months before screening
Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to any drug, in particular antibiotics
Donation or loss of over 500 milliliter (mL) of blood within the three months before screening