In this study we will investigate the safety of the study compound IMU-838 and how well it is tolerated when it is used by healthy subjects. Please note that when the term *study compound* is used in this document, we mean IMU-838.The study will…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the mass balance (recovery), and routes and extent of elimination of
a single oral dose of 45 mg [14C]-IMU-838 containing approximately 0.1998 MBq
(5.4 µCi) of total radioactivity (TRA) in healthy male subjects
Secondary outcome
To assess the safety and tolerability of a single oral dose of 45 mg [14C] IMU
838 containing approximately 0.1998 MBq (5.4 µCi) of TRA in healthy male
subjects
To further characterize the pharmacokinetics (PK) of a single oral dose of 45
mg [14C]-IMU-838 in healthy male subjects
To identify and characterize metabolites of [14C]-IMU-838 in plasma, urine, and
feces
Background summary
Vidofludimus calcium (IMU-838) is a compound that may potentially be used for
the treatment of multiple sclerosis (including progressive multiple sclerosis,
relapsing multiple sclerosis, and relapsing remitting multiple sclerosis), as
well as a rare chronic liver disease ( also known as primary sclerosing
cholangitis), inflammatory bowel disease (ie, ulcerative colitis and Crohn*s
disease), and hospitalized patients with moderate coronavirus disease 19
(COVID-19).
IMU-838 has been used by humans before. In addition, IMU-838 has been
extensively investigated and tested in the laboratory in various animal models
(including mouse, rat, and dog).
The active substance of IMU-838 is vidofludimus calcium. It is a compound that
inhibits the human enzyme dihydroorotate dehydrogenase (DHODH). Inhibiting
DHODH causes specific changes at the cellular level, reduces inflammation
associated with multiple sclerosis and may be beneficial for a variety of
diseases. These diseases include viral infections, chronic inflammatory and
autoimmune diseases.
Study objective
In this study we will investigate the safety of the study compound IMU-838 and
how well it is tolerated when it is used by healthy subjects. Please note that
when the term *study compound* is used in this document, we mean IMU-838.
The study will also investigate how quickly and to what extent IMU-838 is
absorbed, transported, and eliminated from the body (this is called
pharmacokinetics). For this study, IMU-838 is radioactively labeled with
carbon-14 (14C) to trace the study drug in blood, urine, and feces and to
estimate routes and extent of excretion of radioactivity.
Study design
The study takes a maximum of 9 weeks from the screening to the follow-up. A
total of 7 adult men will participate in the study.
Day 1 is the day of receiving study drug (IMU 838). For the research it is
necessary to stay in the research center for 1 period of 11 days (10 nights).
If necessary, this period can be extended by a maximum of 4 days (3 nights).
The time between the examination and the final stay depends on the amount of
radioactivity remaining in the urine and faeces at the end of the examination
(Day 10). The amount of radioactivity in urine and faeces is measured daily
from Day 1. If on Day 10 the radioactivity levels in urine and faeces are below
predefined levels, one may leave the study center. If eligibility criteria are
not met on Day 10, patients must remain in the study center for up to 4
additional days (Days 11 to 14) until eligibility criteria are met. If
discharge criteria are still not met on Day 14, the person will be discharged
and asked to collect stool samples at home 24 hours prior to the stay and bring
these samples to the Clinical Research Center during the 24-hour visit on Days
21-22 , 28-29 and/or 35/36. Urine and stool samples are collected during the
24-hour visits. For these collection moments, people are expected in the
research center on these days. The volunteer receives a follow-up phone call 3
to 7 days after the last stay
The volunteer will receive 45 mg of [14C]-IMU-838 as a 250 milliliter (ml)
drink by mouth. After administration of the study drug, the vial will be rinsed
twice with 50 ml of water, which should also be drunk.
Intervention
On Day 1; 45 mg of [14C] IMU-838 as an oral solution, once
Study burden and risks
Blood collection
Blood tests can hurt or cause bruising. The use of an indwelling cannula can
sometimes lead to inflammation, swelling, hardening of the artery, or blood
clotting and bleeding around the puncture site. In some individuals, a blood
draw can sometimes cause pallor, nausea, sweating, low heart rate, or drop in
blood pressure with dizziness or fainting.
All in all, we take approximately 402 milliliters (ml) of blood from the test
to the follow-up. This amount does not cause problems in adults.
ECG
Electrodes are placed on the arms, chest and legs to make a heart film.
Prolonged application of these electrodes may cause skin irritation.
Fasting
If you have to fast for a long time during the study, this can lead to
complaints such as dizziness, headache, stomach complaints or fainting.
Coronavirus tests
Samples for the coronavirus test will be taken from the back of the nose and
throat with cotton swabs. Taking the samples only takes a few seconds, but can
cause discomfort and an unpleasant feeling. Taking a sample from the back of
the throat can cause gagging. When the sample is taken from the back of the
nose, a stinging sensation may be experienced and the eyes may water.
Lochhamer Schlag 21
Graefeling 82166
DE
Lochhamer Schlag 21
Graefeling 82166
DE
Listed location countries
Age
Inclusion criteria
1. Sex: Male subjects.
2. Age: 18 to 45 years, inclusive, at screening.
3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
4. Weight: >=50 kg at screening.
Exclusion criteria
1. Previous participation in the current study.
2. Employee of ICON plc or the Sponsor.
3. History of relevant drug and/or food allergies.
4. Using tobacco products within 60 days prior to the drug administration.
5. History of alcohol abuse or drug addiction (including soft drugs like
cannabis products) in the past 2 years.
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 | EUCTR2022-003181-21-NL |
| CCMO | NL83270.056.22 |