The purpose of the study is to investigate how quickly and to what extent UCB0599 and UCB2713 are absorbed, distributed, metabolized (broken down) and excreted from the body (this is called pharmacokinetics). Since UCB0599 and UCB2713 will be…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Please refer to the protocol for more details, below the two main criteria:
- To evaluate the excretion balance of 14C labeled UCB0599 and 14C labeled
UCB2713 administered orally together with oral UCB1332 (Part A)
- To evaluate the plasma and CSF PK profiles of UCB0599 and UCB2713 and their
respective desmethyl metabolites when administered intravenously as 14C-labeled
tracer together with an oral loading dose of UCB1332 (Part B)
Secondary outcome
• To determine the protein binding of total radioactivity, UCB0599 and UCB2713
and their respective desmethyl metabolites, in plasma and CSF, if permitted by
analytical sensitivity (Part B)
• To document the single dose safety and tolerability of UCB1332.
Background summary
UCB1332 is a new investigational compound that may eventually be used for the
treatment of Parkinson*s disease. Alpha synuclein is a protein that is present
in the human body, especially in the brain where it plays a role in processes
in the brain cell and in communication between brain cells. In patients with
Parkinson*s disease, accumulation of this protein takes place which disturbs
the normal processes in and between brain cells. UCB1332 interacts with alpha
synuclein and thereby prevents the accumulation of the protein and is therefore
considered to reduce the intensity of the symptoms of Parkinson*s disease.
UCB1332 is in development and is not registered as a drug but has been given to
humans before.
Study objective
The purpose of the study is to investigate how quickly and to what extent
UCB0599 and UCB2713 are absorbed, distributed, metabolized (broken down) and
excreted from the body (this is called pharmacokinetics). Since UCB0599 and
UCB2713 will be radiolabeled in Parts A and B, UCB0599 and UCB2713 can be
traced in blood (Parts A and B), cerebrospinal fluid (Part B only), and urine
and feces (Part A only). Another purpose in both Parts A and B of the study is
to investigate to what extent the administered study compounds are tolerated.
Study design
Part A:
The study will consist of 1 period during which the volunteers will stay in the
research centre from Day -1 to at least Day 8. If on Day 8, the radioactivity
levels in the urine and feces are above pre-defined levels, the volunteers will
have to stay in the clinical research center, and the radioactivity levels in
the urine and feces will be checked every day until a maximum of Day 11.
Part B:
The study will consist of 1 period during which the volunteers will stay in the
clinical research center from Day -1 to Day 3. It may be decided by the medical
doctor that the volunteer will need to stay in the clinical research center for
a longer period of time.
Intervention
The study will be performed in 2 parts in a total of 14 healthy male
volunteers.
Part A will consist of 8 volunteers. All 8 volunteers will receive 30
milligrams UCB1332 as 2 oral capsules. 4 volunteers in Group 1, 1 of the 2
capsules with UCB1332 will also contain a small dose of 20 micrograms of
UCB0599 which will be labeled with 14-Carbon. For the 4 volunteers in Group 2,
1 of the 2 capsules with UCB1332 will also contain a small dose of 20
micrograms of radiolabeled UCB2713.
Part B will consist of 6 volunteers; 3 volunteers will receive 30 milligrams
UCB1332 and a small dose of 20 micrograms of 14C UCB0599 as an intravenous
infusion. 3 volunteers will receive 30 milligrams UCB1332 and a small dose of
20 micrograms of 14C UCB2713 as an infusion in a vein.
Study burden and risks
Please refer to the protocol and IB for treatment related adverse events.
Adverse events related to procedures: Pain, minor bleeding, bruising and
possible infection
Allée de la Recherche 60
Brussels B-1070
BE
Allée de la Recherche 60
Brussels B-1070
BE
Listed location countries
Age
Inclusion criteria
healthy male subjects
18 - 55 years
50 - 100 kg
BMI 18 - 30 kg/m2
non-smoking
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design
Recruitment
Medical products/devices used
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 | EUCTR2015-003591-68-NL |
CCMO | NL55619.056.15 |