A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/25/2018 |
| Start Date: | June 15, 2017 |
| End Date: | August 10, 2017 |
A Non-Randomized, Open Label, One Treatment, One Group Study to Investigate the Intrapulmonary Lung Penetration of RO7079901 in Healthy Volunteers
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.
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.
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
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