In this study we will investigate how quickly and to what extent carbidopa and levodopa are absorbed, transported, and eliminated from the body when administered as the study compound, the CLE-600 oral system. We will also investigate the safety and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- CD and LD PK parameters: Cmax, Tc above 450ng/ml, Tmax, AUC0-t, AUC0-inf,
t1/2, Tlag as applicable
- Safety and tolerability: Incidence of adverse events, vital signs, clinical
laboratory tests and ECG
Secondary outcome
N/A
Background summary
The CLE-600 oral system is an oral system for administration of the Parkinson*s
disease (PD) medications carbidopa and levodopa. Many PD patients are treated
with levodopa and carbidopa taken a few times a day to improve the symptoms of
the disease.
One problem that PD patients face is the wearing off of the effect of levodopa
before the next dose of medication. It can also happen in the night and early
morning. The CLE-600 oral system is being developed to counteract possible
wearing off in the night or early morning. The CLE-600 oral system can store
multiple tablets of PD medication. After ingestion of the CLE-600 oral system
the platform unfolds in the stomach and slowly releases the medication. It is
estimated that the medication will be released over 8 to 10 hours. Thereafter
the platform disassembles and is excreted via the stool.
Study objective
In this study we will investigate how quickly and to what extent carbidopa and
levodopa are absorbed, transported, and eliminated from the body when
administered as the study compound, the CLE-600 oral system. We will also
investigate the safety and how well the study compound is tolerated when used
by patients with Parkinson*s disease.
The study compound is the CLE-600 oral system, which is composed of a delivery
platform with carbidopa and levodopa inside. The CLE-600 oral system is folded
into a capsule for swallowing, and unfolds back to a triangular shape in the
stomach, which allows long-acting release of the medication.
All subjects receive a standardized meal before each oral administration of the
CLE-600 oral system (either a light meal, a moderate-fat meal or a high-fat
meal) during the study. We use different types of meal to further test the
absorption of the study compound.
Study design
In total the volunteer will visit the research center 2 or 3 times:
Part A:
Screening: Day -21 up to Day -1
Arrival: Day 1
In-house stay: Day 1 up to Day 3
Departure: Day 3
Follow-up (if needed): Between Day 6 and Day 8
Part B:
Screening: Day -21 up to Day 1
Arrival: Day -1
In-house stay: Day -1 up to Day 3
Departure: Day 3
Follow-up (if needed): Between Day 6 and Day 8
The volunteer will be given CLE-600 with 50 mg carbidopa and 500 mg levodopa
twice (one administration per evening on 2 consecutive evenings) as an oral
capsule with 240 milliliters (mL) of (tap) water.
Intervention
The volunteer will be given the CLE-600 oral system which contains 50 mg
carbidopa and 500 mg levodopa twice (one administration per evening on 2
consecutive evenings) as an oral capsule with 240 milliliters (mL) of (tap)
water.
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula can sometimes lead to inflammation, swelling, hardening of the vein,
blood clotting, and bleeding in the environment of 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.
In total, we will take not more than 325 (Part A) / 281 (Part B) milliliters
(mL) of blood from the volunteer from screening to follow-up. This amount does
not cause any problems in adults.
Heart tracing
To make a heart tracing, electrodes will be placed on the arms, chest and legs.
Prolonged use of these electrodes can cause skin irritation.
Meals/Fasting
The standardized meals are either a standardized light meal, moderate-fat meal
or high-fat meal. The volunteer must consume the whole meal. It can be
difficult to consume the entire fat meals, particularly for light eaters.
If the volunteer has to fast for a prolonged time during the study, this may
lead to symptoms such as dizziness, headache, stomach upset, or fainting.
Coronavirus test
Samples for the coronavirus test will be taken from the back of the nose and
throat using swabs. Taking the samples only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
the throat may cause the volunteer to gag. When the sample is taken from the
back of the nose, the volunteer may experience a stinging sensation and the
eyes may become watery.
Haftzadi St. 21
Jerusalem 9548402
IL
Haftzadi St. 21
Jerusalem 9548402
IL
Listed location countries
Age
Inclusion criteria
1. Sex : male or female; females must be of nonchildbearing potential or
postmenopausal.
2. Age : 40 to 80 years, inclusive, at screening.
3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening.
4. Weight : >=50 kg, at screening.
5. Status : PD patients (diagnosed according to UK PD Society Brain Bank
Criteria).
Further criteria apply
Exclusion criteria
1. Previous participation in the current study.
2. Employee of ICON or the Sponsor.
3. History of alcohol abuse or drug addiction within the last year (including
soft drugs like cannabis products), except for tobacco use disorder.
4. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, and alcohol)
at screening or admission (Day 1 for Part A and Day -1 for Part B) to the
clinical research center. For cannabinoids, in case of a positive screen the
Investigator should decide whether this is related to medical or recreational
use (then subject may be included) or to drug addiction (then subject should be
excluded).
5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
Further criteria apply
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 | EUCTR2022-001855-17-NL |
| CCMO | NL82986.056.22 |