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Clinical Trials/ISRCTN77943537
ISRCTN77943537
Completed
Phase 1

A fixed-sequence, drug-drug interaction study evaluating the effect of the cytochrome P450 3A inhibitor itraconazole on DNL343 in healthy participants

Denali Therapeutics (United States)0 sites24 target enrollmentMarch 14, 2024
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Denali Therapeutics (United States)
Enrollment
24
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 14, 2024
End Date
July 25, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Denali Therapeutics (United States)

Eligibility Criteria

Inclusion Criteria

  • •1\. Healthy male participants and healthy female participants of non\-childbearing potential
  • •2\. Aged \=18 to \=55 years
  • •3\. Body mass index (BMI) of \=18\.5 to \=30 kg/m²
  • •4\. Body weight of \=50 kg

Exclusion Criteria

  • •1\. History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
  • •2\. History of malignancy, except fully resected basal cell carcinoma
  • •3\. History of clinically significant neurological or psychiatric diseases
  • •4\. History of serious adverse reaction or serious hypersensitivity to any drug, or history of allergy to any component of the DNL343 or itraconazole products
  • •5\. Are pregnant (ie, positive pregnancy test) or breastfeeding

Outcomes

Primary Outcomes

Not specified

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