Drug-Drug interaction study in HV
- Conditions
- Parkinson's disease.
- Registration Number
- NL-OMON28697
- Lead Sponsor
- Denali Therapeutics, Inc
- Brief Summary
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objectives of the study are to estimate the following:<br /><br>•The measurable maximum plasma concentration (Cmax) of DNL151 in the<br>presence and absence of ITZ<br /><br>•The area under the concentration-time curve (AUC) of DNL151 in the presence<br>and absence of ITZ<br /><br>•The terminal half-life of DNL151 in the presence and absence of ITZ<br>
- Secondary Outcome Measures
Name Time Method Safety and tolerability of administration of DNL151 alone and in the presence of ITZ