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

  • Bacterial Infection
Trial Status:

Completed

This trial runs in
Cities
  • Phoenix
Trial Identifier:

NCT03182504 2016-004478-16 NP39750

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03182504 , NP39750 , 2016-004478-16 Trial Identifier
      nacubactam, meropenem Treatments
      Gram-negative Bacterial Infections Condition
      Official Title

      A Non-Randomized, Open Label, One Treatment, One Group Study to Investigate the Intrapulmonary Lung Penetration of RO7079901 in Healthy Volunteers

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 60 Years Age
      Accepts Healthy Volunteers 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

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