No registrations found.
ID
Source
Brief title
Health condition
Parkinson's disease.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objectives of the study are to estimate the following:
• The measurable maximum plasma concentration (Cmax) of DNL151 in the
presence and absence of ITZ
• The area under the concentration-time curve (AUC) of DNL151 in the presence
and absence of ITZ
• The terminal half-life of DNL151 in the presence and absence of ITZ
Secondary outcome
Safety and tolerability of administration of DNL151 alone and in the presence of ITZ
Background summary
This was a single center study, all healthy volunteers were recruited in the Netherlands
Study objective
LRRK2 kinase inhibitors represent a new class of therapeutics with potential to address the underlying biology of Parkinson’s disease. LRRK2 activity is linked to a central mechanisms of Parkinson’s disease pathology through its role in lysosomal function. DNL151 is an inhibitor of LRRK2 kinase, a genetically validated target, and is expected to impede the underlying disease process. Therefore, DNL151 may prevent or slow the progression of motor and nonmotor disabilities that define the progression of Parkinson’s disease.
Study design
Up to follow-up phase
Intervention
DNL151
Itraconazole
Zernikedreef 8
J. Heuberger Centre for Human Drug Research
Leiden 2333 CL
The Netherlands
+ 31 71 5246 400
clintrials@chdr.nl
Zernikedreef 8
J. Heuberger Centre for Human Drug Research
Leiden 2333 CL
The Netherlands
+ 31 71 5246 400
clintrials@chdr.nl
Inclusion criteria
Subjects enrolled in the study were required to meet all the following criteria for study entry:
• Men or women of any race, between 18 and 50 years of age, inclusive, at screening
• BMI between 18.0 and 31.0 kg/m2, inclusive, and a body weight of at least 50.0 kg at Screening
• In good health determined by no clinically significant findings from medical history, physical examination, and vital sign measurements
• All clinical laboratory tests must be within normal limits or no clinically significant abnormalities
Exclusion criteria
Subjects who met any of the following criteria were excluded from study entry:
• History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders as determined by the investigator
• Abnormal vital signs at screening
• Clinically significant neurologic disorder
• Evidence of ANY hepatic impairment
• Clinically significant ECG abnormality at screening
• History of clinically significant congestive heart failure.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7350 |
| NTR-old | NTR7559 |
| Other | Stichting BEBO : CHDR1840 |