Gram-negative Bacterial InfectionsPhase 1NCT03182504
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants
A Phase 1 study testing nacubactam and meropenem in people with Gram-negative Bacterial Infections, run by Hoffmann-La Roche at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gram-negative Bacterial Infections
- What is being tested?
- nacubactam and meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 10 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary Associates Clinical Trials (PACT)
Phoenix, Arizona, 85006
About this study
Official title: 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.
- Conditions
- Gram-negative Bacterial Infections
- Being tested
- nacubactam, meropenem
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nacubactamDrug
Also called RO7079901
Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.
meropenemDrug
Also called Merrem
Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Nacubactam Plus Meropenem | Experimental | Participants will receive a single dose of nacubactam co-administered with meropenem. Receives: Drug: nacubactam; Drug: meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial Lining Fluid (ELF) Concentration of Nacubactam to Plasma Concentration of Nacubactam Ratio
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.
Measured: At 2, 3, 4, 6 and 8 hours after study drug administration
Secondary outcomes (18)
ELF Concentration of Meropenem to Plasma Concentration of Meropenem Ratio
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..
Measured: 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
Measured: At 2, 3, 4, 6 and 8 hours after study drug administration
Maximum Concentration (Cmax) of Nacubactam in ELF
Measured: 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
Measured: 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
Measured: 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
Measured: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Clearance (CL) of Nacubactam
Measured: 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
Measured: 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
Measured: 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
Measured: At 2, 3, 4, 6 and 8 hours after study drug administration
Maximum Concentration (Cmax) of Meropenem in ELF
Measured: 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
Measured: 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
Measured: 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
Measured: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Clearance (CL) of Meropenem
Measured: 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
Measured: 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
Measured: At 0, 0.75, 1.5, 2, 3, 4, 6 and 8 hours after study drug administration
Number of Participants with Adverse Events
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.
Measured: From baseline up to 14 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start15 Jun 2017
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-negative Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182504
- Sponsor's protocol ID
- NP39750
- Other IDs
- 2016-004478-16, 2016
- Status last verified
- Apr 2018
- First submitted
- 7 Jun 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Morita J, Ishiwata K, Matsumoto S, Kato S, Attley G, Patel K, Rodriguez I, Mallalieu NL. Evidence of intrapulmonary penetration of nacubactam, a novel beta-lactamase inhibitor, following coadministration of nacubactam with meropenem in healthy adults. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0002626. doi: 10.1128/aac.00026-26. Epub 2026 Apr 30.
PubMed 42059802
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open Label, One Treatment, One Group Study to Investigate the Intrapulmonary Lung Penetration of RO7079901 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03182504
- Acronym / sponsor ID
- NP39750
- Conditions
- Gram-negative Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nacubactam Plus Meropenem | Experimental | Drug: nacubactam, Drug: meropenemParticipants will receive a single dose of nacubactam co-administered with meropenem. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nacubactamAlso: RO7079901Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours. | Drug | Nacubactam Plus Meropenem |
| meropenemAlso: MerremParticipants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours. | Drug | Nacubactam Plus Meropenem |
Primary outcome
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.
18 secondary outcomes
ELF Concentration of Meropenem to Plasma Concentration of Meropenem Ratio
Time frame: 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
Maximum Concentration (Cmax) of Nacubactam in ELF
Time frame: 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
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
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
Clearance (CL) of Nacubactam
Time frame: 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
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
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
Maximum Concentration (Cmax) of Meropenem in ELF
Time frame: 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
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
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
Clearance (CL) of Meropenem
Time frame: 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
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
Number of Participants with Adverse Events
Time frame: From baseline up to 14 days after study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Derived from this study: PubMed 42059802Morita J, Ishiwata K, Matsumoto S, Kato S, Attley G, Patel K, Rodriguez I, Mallalieu NL. Evidence of intrapulmonary penetration of nacubactam, a novel beta-lactamase inhibitor, following coadministration of nacubactam with meropenem in healthy adults. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0002626. doi: 10.1128/aac.00026-26. Epub 2026 Apr 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nacubactam and meropenem in people with Gram-negative Bacterial Infections, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.