Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03182504
NCT03182504CompletedPhase 1

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

Hoffmann-La Roche1 site in 1 country21 target enrollmentStarted: June 15, 2017Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Nacubactam Plus Meropenem

Experimental

Participants will receive a single dose of nacubactam co-administered with meropenem.

Intervention: nacubactam (Drug)

Nacubactam Plus Meropenem

Experimental

Participants will receive a single dose of nacubactam co-administered with meropenem.

Intervention: meropenem (Drug)

Outcomes

Primary Outcomes

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

  • 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)
  • 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)
  • 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)
  • Maximum Concentration (Cmax) of Nacubactam in ELF(At 2, 3, 4, 6 and 8 hours after study drug administration)
  • 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)
  • 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)
  • Maximum Concentration (Cmax) of Meropenem in ELF(At 2, 3, 4, 6 and 8 hours after study drug administration)
  • Clearance (CL) of Meropenem(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
  • 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)
  • Clearance (CL) of Nacubactam(At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration)
  • 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)
  • ELF Concentration of Meropenem to Plasma Concentration of Meropenem Ratio(At 2, 3, 4, 6 and 8 hours after study drug administration)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Number of Participants with Adverse Events(From baseline up to 14 days after study drug administration)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy SubjectsHealthy Subjects
NCT04951505Venatorx Pharmaceuticals, Inc.30
Completed
Phase 2
Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDIAsthma
NCT01349257Chiesi Farmaceutici S.p.A.24
Active, not recruiting
Phase 3
Nipocalimab in Moderate to Severe Sjogren's DiseaseSjogrens Syndrome
NCT06741969Janssen Research & Development, LLC655
Completed
Phase 1
A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's DiseaseHealthy Study ParticipantsParkinson's Disease
NCT04867642UCB Biopharma SRL100
Completed
Phase 1
Intravenous Fosfomycin Pharmacokinetics StudyMultiple-drug ResistancePathogen ResistanceBacterial Infection
NCT03910673National Institute of Allergy and Infectious Diseases (NIAID)39
A Study to Investigate the Intrapulmonary... | Clinical Trial