OPEN-LABEL, NON-RANDOMIZED STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS, AND METABOLISM OF A SINGLE INTRAVENOUS DOSE OF [14C]-LABELED RO7223280 IN HEALTHY MALE PARTICIPANTS
- Conditions
- infections caused by bacteria A. baumanniitreatment of infections caused by bacterium A. baumannii.
- Registration Number
- NL-OMON51844
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize mass balance, rates, and routes of elimination of<br /><br>[14C/12C]-labeled RO7223280, using conventional analytical methods (and<br /><br>accelerator mass spectrometry [AMS] if necessary)<br /><br><br /><br>To assess the pharmacokinetics (PK) of total drug-related [14C]-radioactivity,<br /><br>[12C] RO7223280 and its metabolite(s), as appropriate, using conventional<br /><br>analytical methods (and AMS, if necessary)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To identify and quantify the metabolic profiles of RO7223280 in plasma, blood<br /><br>pellet (if appropriate), urine, and feces on the basis of [14C]-radioactive<br /><br>metabolic profiling, and characterize any major metabolite(s), using<br /><br>conventional analytical methods (and AMS, if necessary)<br /><br><br /><br>To assess the safety and tolerability of a single intravenous dose of RO7223280<br /><br>in healthy participants</p><br>