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

NCT ID: NCT03182504

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2017-08-10

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.

Conditions

Gram-negative Bacterial Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nacubactam Plus Meropenem

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

Group Type: EXPERIMENTAL

nacubactam

Intervention Type: DRUG

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

meropenem

Intervention Type: DRUG

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

Interventions

nacubactam

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

Intervention Type: DRUG

meropenem

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

Intervention Type: DRUG

Other Intervention Names

RO7079901; Merrem

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Pulmonary Associates Clinical Trials (PACT)

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

2016-004478-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NP39750

Identifier Type: -

Identifier Source: org_study_id