The purpose of this study is to investigate how quickly and to what extent LNP023 is absorbed, broken down, and eliminated from the body (this is called pharmacokinetics). LNP023 will be labelled with 14 carbon (14C) and is thus radioactive. In this…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To characterize the plasma pharmacokinetics (PK) of LNP023 and key metabolites,
if applicable.
To determine the PK of total radioactivity in blood and plasma.
To determine the rates and routes of excretion of [14C]LNP023-related
radioactivity, including mass balance of total drug-related radioactivity in
urine and feces following a single 100-mg oral dose of [14C]LNP023 in healthy
volunteers (HV).
Secondary outcome
To assess the safety and tolerability of a single 100-mg oral dose of
[14C]LNP023 administered to HV.
Background summary
LNP023 is a new compound that may eventually be used for the treatment of
autoimmune diseases, by influencing the alternative pathway of the complement
system. This pathway plays an important role in the immune system*s natural
defense against microorganisms. However, hyperactivity of the alternative
pathway is known to cause and/or worsen a wide number of diseases with
autoimmune components. LNP023 is a novel compound that inhibits a certain
factor in the alternative pathway, and thereby has the potential to treat
patients with diseases that are driven by this route of the complement system.
This would represent a major unmet medical need.
Study objective
The purpose of this study is to investigate how quickly and to what extent
LNP023 is absorbed, broken down, and eliminated from the body (this is called
pharmacokinetics). LNP023 will be labelled with 14 carbon (14C) and is thus
radioactive. In this way LNP023 can be traced in blood, urine, and feces.
LNP023 has been administered to humans before. It has also been previously
tested in the laboratory and on animals.
It will also be investigated how safe the new compound LNP023 is and how well
it is tolerated when it is administered to healthy volunteers.
Furthermore, the effect of your genetic information on your body*s response to
LNP023 will be investigated (this is called pharmacogenetics). This is a
mandatory part of this study.
Study design
The participation from screening until the follow-up visit will last up to 8.5
weeks.
The volunteers will once receive 100 milligram (mg) of 14C-labeled LNP023 as an
oral capsule with 240 milliliters (mL) of (tap) water. This amount contains 3.7
MBq (100 µCi) radioactivity. One of the investigators will inspect the hands
and mouth after intake of the study treatment. All subjects will receive the
same study treatment.
The study will consist of 1 period during which the volunteers will stay in the
research center for 11 days (10 nights).
Day 1 is the day of administration of the study treatment. They are expected at
the research center at 14:00 h in the afternoon prior to the day of
administration of the study treatment, so on Day -1. They will leave the
research center on Day 10 of the study.
During their stay, the urine and feces will be collected each day to measure
the amount of radioactivity in urine and feces. The volunteers should be aware
that when the amount of radioactivity in urine and feces is still above
pre-defined levels on Day 10, they will have to return to the research center
for a maximum of 4 additional overnight visits for 24-hour collection of urine
and feces, and for blood sampling.
Intervention
Not applicable.
Study burden and risks
Pain, minor bleedings, bruises, possibly an infection. This study involves
using radioactive markers. The additional amount of radiation you will be
exposed to in this study is 0.07 mSv (millisievert [unit to measure
radiation]). To compare: the background radiation in the Netherlands is ~2.5
mSv per year. The additional radiation you will be exposed to in this study is
thus ~3% compared to the average yearly annual radiation burden and is
considered acceptable.
Lichtstrasse 35
Basel CH-4056
CH
Lichtstrasse 35
Basel CH-4056
CH
Listed location countries
Age
Inclusion criteria
healthy male / female of non-childbearing potential
18 - 55 years
more than 50 kilograms.
BMI 18.0 - 30.0 kilograms / meter2
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
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 | EUCTR2019-001407-20-NL |
| CCMO | NL70000.056.19 |