In this study we will investigate how quickly and to what extent RO7223280 is distributed, metabolized, and eliminated from the body. For this study, RO7223280 is radioactively labelled with carbon-14 (14C). In this way RO7223280 can be traced in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
infections caused by bacteria A. baumannii
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
RO7223280 is a new compound that may potentially be used for the treatment of
infections caused by bacterium A. baumannii. This bacterium has high rates of
resistance to multiple antibiotics. RO7223280 targets an essential bacterial
process in A. baumannii which is not targeted by currently available
antibiotics. This bacteria type is most commonly found in hospitals in people
with a compromised immune system. Furthermore, it is prevalent in Asia, parts
of Europe, the Middle East and South America.
Study objective
In this study we will investigate how quickly and to what extent RO7223280 is
distributed, metabolized, and eliminated from the body. For this study,
RO7223280 is radioactively labelled with carbon-14 (14C). In this way RO7223280
can be traced in blood, urine, and feces.
We also investigate how safe the new compound RO7223280 is and how well it is
tolerated when it is used by healthy participants.
We also look at the effect of your genetic information on your body*s response
to RO7223280. This part of the study is mandatory.
At the time of writing this form, there are two ongoing studies with RO7223280
in healthy adult participants.
Study design
The study lasts a maximum of 8 weeks from the inspection to the follow-up check.
For the research it is necessary to stay in the research center for 1 period of
at least 16 days (15 nights). The volunteer may leave the research center on
Day 15 if the body has excreted at least 95% of the radioactivity. If the total
amount of radioactivity excreted in urine and faeces on Day 15 is below this
limit value, the stay may be extended by 7 days to Day 22. After this there is
one more follow-up visit to the research center. This short visit will take
place approximately 7 days (5-9 days) after the last urine and fecal samples
have been collected.
Day 1 is the day on which the study drug is received. We expect the volunteer
at the study center on the day prior to the administration of the study drug.
You must report to the research center between 9:30 a.m. and 2:00 p.m. One
leaves the study center on either Day 15 or Day 22 of the study.
The volunteer receives 1000 mg of 14C labeled RO7223280 as a 1 hour intravenous
infusion.
Intervention
Not applicable.
Study burden and risks
Blood draw
Blood draws may hurt or cause bruising. Using an indwelling cannula can
sometimes cause inflammation, swelling, hardening of the artery, or blood
clotting and bleeding around the puncture site. In some individuals, a blood
draw can sometimes cause paleness, nausea, sweating, slow heart rate, or drop
in blood pressure with dizziness or fainting.
All in all, from the inspection to the follow-up check, we take up to 410
milliliters (mL) of blood from you. This amount does not cause any problems in
adults. If the investigator deems this necessary to ensure the safety of the
participant, additional samples may be taken for any additional testing. If
this happens, the total amount of blood drawn may be more than the amount
indicated above.
ECG
To make a heart film, electrodes are placed on the arms, chest and legs.
Prolonged use of these electrodes may cause skin irritation.
Coronavirus test
Samples for the coronavirus test will be taken with cotton swabs at the back of
the nose and throat. Collecting the samples only takes a few seconds, but can
cause discomfort and discomfort. Taking a sample from the back of the throat
may result in gagging. When the sample is taken at the back of the nose, you
may experience a stinging sensation and the eyes may water.
Grenzacherstrasse 124
Basel 4070
CH
Grenzacherstrasse 124
Basel 4070
CH
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001155-16-NL |
| CCMO | NL81447.056.22 |