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

April 20, 2018 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates Clinical Trials (PACT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nacubactam Plus Meropenem
Participants will receive a single dose of nacubactam co-administered with meropenem.
Drug: nacubactam
Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.
Other Names:
  • RO7079901
Drug: meropenem
Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.
Other Names:
  • Merrem

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 2, 3, 4, 6 and 8 hours after study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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..
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 ELF
Time Frame: At 2, 3, 4, 6 and 8 hours after study drug administration
At 2, 3, 4, 6 and 8 hours after study drug administration
Maximum Concentration (Cmax) of Nacubactam in ELF
Time Frame: At 2, 3, 4, 6 and 8 hours after study drug administration
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Clearance (CL) of Nacubactam
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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
Time Frame: At 2, 3, 4, 6 and 8 hours after study drug administration
At 2, 3, 4, 6 and 8 hours after study drug administration
Maximum Concentration (Cmax) of Meropenem in ELF
Time Frame: At 2, 3, 4, 6 and 8 hours after study drug administration
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Clearance (CL) of Meropenem
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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
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
Time Frame: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
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.
From baseline up to 14 days after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP39750
  • 2016-004478-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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