Parkinson's disease.
Conditions
Interventions
DNL151
Itraconazole
Sponsors
Denali Therapeutics, Inc
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety and tolerability of administration of DNL151 alone and in the presence of ITZ | — |
Contacts
Public ContactJ. Heuberger Centre for Human Drug Research
Zernikedreef 8
Outcome results
None listed