NL-OMON28697
Completed
N/A
A FIXED-SEQUENCE CROSSOVER, DRUG-DRUG INTERACTION STUDY IN HEALTHY SUBJECTS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Denali Therapeutics, Inc
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
o
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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