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NCT Number: NCT03182504

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

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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Key information

Conditions

Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates Clinical Trials (PACT)

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nacubactam

Drug

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

Other names: RO7079901

Meropenem

Drug

Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.

Other names: Merrem

Primary outcomes

  1. Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio

    Time frame: At 2, 3, 4, 6 and 8 hours after study drug administration

    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.

Secondary outcomes

  1. ELF Concentration of Meropenem to Plasma Concentration of Meropenem Ratio

    Time frame: At 2, 3, 4, 6 and 8 hours after study drug administration

    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..

  2. Area Under the Plasma Concentration-Time Curve from time 0 to 8 hours (AUC0-8) of Nacubactam in ELF

    Time frame: At 2, 3, 4, 6 and 8 hours after study drug administration

  3. Maximum Concentration (Cmax) of Nacubactam in ELF

    Time frame: At 2, 3, 4, 6 and 8 hours after study drug administration

  4. Area Under the Plasma Concentration-Time Curve from Time 0 to 8 Hours (AUC0-8) of Nacubactam in Blood Plasma

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  5. Maximum Concentration (Cmax) of Nacubactam in Blood Plasma

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  6. Time to Reach the Maximum Plasma Concentration (Tmax) of Nacubactam

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  7. Clearance (CL) of Nacubactam

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  8. Volume of Distribution of the Central Compartment (Vc) of Nacubactam

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  9. Volume of Distribution at Steady-State (Vss) of Nacubactam

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  10. Area Under the Plasma Concentration-Time Curve from Time 0 to 8 Hours (AUC0-8) of Meropenem in ELF

    Time frame: At 2, 3, 4, 6 and 8 hours after study drug administration

  11. Maximum Concentration (Cmax) of Meropenem in ELF

    Time frame: At 2, 3, 4, 6 and 8 hours after study drug administration

  12. Area Under the Plasma Concentration-Time Curve from Time 0 to 8 hours (AUC0-8) of Meropenem in Blood Plasma

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  13. Maximum Concentration (Cmax) of Meropenem in Blood Plasma

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  14. Time to Reach the Maximum Plasma Concentration (Tmax) of Meropenem

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  15. Clearance (CL) of Meropenem

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  16. Volume of Distribution of the Central Compartment (Vc) of Meropenem

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  17. Volume of Distribution at Steady-State (Vss) of Meropenem

    Time frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration

  18. Number of Participants with Adverse Events

    Time frame: From baseline up to 14 days after study drug administration

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2017
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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