NL-OMON42834
Completed
Not Applicable
A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of DNL104 in Healthy Subjects - Single Ascending Oral Doses of DNL104
Denali Therapeutics0 sites48 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 10029317
- Sponsor
- Denali Therapeutics
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Healthy male or female of non\-childbearing potential between 18 to 65 years of age at screening (inclusive).
- •2\.Subjects must be willing and able to give written informed consent by signing an EC\-approved Informed Consent Form prior to admission to
- •this study.
- •3\.Body mass index between 19 to 32 kg/m2 (inclusive) and a weight of at least 50 kg.
- •4\.For males: subject and his female spouse/partners who are of childbearing potential must use highly effective contraception when
- •engaging in sexual activity consisting of 2 forms of birth control (1 of which must be a barrier method such as latex or polyurethane condoms)
- •starting at screening and continuing throughout the clinical study period, and for 90 days after the final study drug administration.
- •5\.For males: subject must not donate sperm starting at screening and throughout the clinical study period, and for 90 days after the final study
- •drug administration.
- •6\.For females: subject must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of \<200 pmol/L and follicle\-stimulating hormone level of \>40 IU/L at screening).
Exclusion Criteria
- •1\. History of clinically significant hematological, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders.
- •2\. Current significant medical or psychiatric condition.
- •3\. Clinical laboratory test values outside the normal range at screening or baseline unless assessed by the Investigator as clinically non\-significant values.
- •4\. History or presence of supine systolic blood pressure \<90 or \>140 mmHg, supine diastolic blood pressure \<50 or \>90 mmHg, pulse rate \<40 or \>110 bpm, or elevated body temperature at screening or baseline.
- •5\. Serious adverse reaction or serious hypersensitivity to any drug.
- •6\. Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1\.5 x the upper limit of normal (ULN) or bilirubin \>1\.2 x ULN, or GGT \>2\.5 x ULN, or creatinine clearance (determined by MDRD) of \<30 mL/min.
- •7\. History of seizures.
- •8\. History or presence of an abnormal ECG, including, but not limited to, complete left bundle branch block, second\- or third\-degree heart block, evidence of prior myocardial infarction, or any other abnormality that is clinically significant in the investigator\*s opinion or precludes accurate interpretation and calculations of cardiac intervals (e.g., QT, QRS).
- •9\. A QTcF value \>450 msec or QRS \>120 msec demonstrated by at least two ECGs more than 30 minutes apart.
- •10\. Hemoglobin level \<7\.5 mmol/L.
Outcomes
Primary Outcomes
Not specified
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