A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
NCT ID: NCT06281158
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2024-03-01
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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14C-DNL343
[14C]-DNL343
Single dose
Interventions
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[14C]-DNL343
Single dose
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 18.0 and 32.0 kg/m2
* In good health
* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
* History of a minimum of 1 bowel movement per day
Exclusion Criteria
* Have a history of malignancy, except fully resected basal cell carcinoma
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343
18 Years
65 Years
MALE
Yes
Sponsors
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Denali Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ana-Claire Meyer, MD
Role: STUDY_DIRECTOR
Denali Therapeutics
Locations
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Clinical Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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DNLI-F-0009
Identifier Type: -
Identifier Source: org_study_id
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