A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.

Key facts

Study ID

NCT06281158

Run by

Denali Therapeutics Inc.

People needed

7

Starts

2024-03-01

Expected to finish

2024-04-30

Last updated by the study team

2024-06-20

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males, aged between 18 to 65 years, inclusive
• 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

You may not qualify if…

• History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
• 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• Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343

Where it is running

• Clinical Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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