infections caused by bacteria A. baumannii treatment of infections caused by bacterium A. baumannii.
Conditions
Interventions
Not applicable.
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy Male participants aged 35 to 64 years (inclusive) at screening Participants must weigh at least 50 kg and have a BMI 18-32 kg/m2 (inclusive) at screening
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant gastrointestinal, renal, hepatic, broncho pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis 2. Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study, including but not limited to, any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first study drug administration 3. History or evidence of any medical condition potentially altering the absorption, distribution, metabolism, or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract (with the exception of uncomplicated appendectomy and hernia repair) 4. History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PQ/PR interval * 210 ms, QTcF * 450 ms) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death) 5.History of malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize mass balance, rates, and routes of elimination of [14C/12C]-labeled RO7223280, using conventional analytical methods (and accelerator mass spectrometry [AMS] if necessary) To assess the pharmacokinetics (PK) of total drug-related [14C]-radioactivity, [12C] RO7223280 and its metabolite(s), as appropriate, using conventional analytical methods (and AMS, if necessary) | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify and quantify the metabolic profiles of RO7223280 in plasma, blood pellet (if appropriate), urine, and feces on the basis of [14C]-radioactive metabolic profiling, and characterize any major metabolite(s), using conventional analytical methods (and AMS, if necessary) To assess the safety and tolerability of a single intravenous dose of RO7223280 in healthy participants | — |
Countries
Netherlands
Outcome results
None listed